The Asthma Medical Reasearch Specialist

Opening Hours : Monday to Thursday - 8am to 5pm
  Contact : (915) 544-2557

List of Past Studies

Here is a list of medical research studies that we have conducted over the years.

Western Sky Medical Research

(El Paso Institute for Medical Research and Development)

Lyndon E. Mansfield, MD

Director

2121 Wyoming Ave.

El Paso, Texas 79903

(915) 544-2557

 

List of Research Studies

 

  1. 1. Study 3M-1

A comparison of the lot-to-lot variability of standardized and nonstandardized

allergen extracts.

3M Diagnostics Systems

Santa Clara, CA

Completed:    1988

 

  1. Study 3M-2

A Regional Individual Allergen Based Miniscreen to Predict IgE Mediated Airborne

Allergy

3M Diagnostics Systems

Santa Clara, CA

Completed:    1987

 

  1. Mast Immunosystems

Correlation of Mast Results to Prick Puncture Skin Testing.

Mast Immunosystems

Completed:    1987

  1. Quidel Inc.

Comparison of Quidel method with Allergen Skin Testing.

Quidel

San Diego, CA

Completed:    1987

 

  1. Quidel Inc.

Testing and comparison of dipstick method for Total IgE

Quidel

San Diego, CA

Completed:    1988

 

  1. Study No. SAL 303/313

A double-blind parallel group Multicenter study comparing the efficacy and safety of Albuterol Rotacaps (200mg) vs. Albuterol Aerosol (l8Omcg) administered four times per day in children ages 4 through 11 years with chronic reversible obstructive airway disease.

Glaxo, Inc.

Research Triangle Park, N.C.

Completed 1987

 

  1. Study No. SAL-312

Efficacy and Safety of Ventolin Rotocaps (400 mcg.) in Children Ages 4

Through 11 Years.

Glaxo, Inc.

Research Triangle Park, N.C.

Completed:     1987

  1. Zaditen Study No. 24

A Comparison of Zaditen with Hi and Combination of H1 and H2

Antihistamine in the Inhibition of Dermographia.

Sandoz Research Institute

East Hanover, NJ.

Completed:     1987

 

  1. Study No. 85-36

A Double-Blind Multicenter Group Comparative Study of the

Efficacy and Safety Of Tilade (Nedocromil Sodium) and the Intal

Inhaler (Cromolyn Sodium) Vs. Placebo In the Management of

Adults with Reversible Airways Obstruction.

Fisons Corporation

Bedford, Mass.

Completed:     1986

 

  1. Zaditen Study No. 32

Theophylline Sparing Role of Zaditen in the Prophylaxis of

Predominantly Moderate Extrinsic Asthma.

Sandoz Research Institute

East Hanover, N.J.

Completed:     1989

 

  1. Study No. 87-6

A Double-Blind Multi-Center Group Comparative Study of the

Efficacy and Safety of Intel 5mg. Inhaler (Cromolyn Sodium) Vs.

Placebo in the Management of Patients with Asthma.

Fisons Corporation

Bedford, Mass.

Completed:     1988

 

  1. 3M-3

Correlation between Fast and Prick Puncture Skin Testing.

3M Diagnostics Systems

Santa Clara, Ca.

Completed:     1988

 

  1. Study No. 198

Placebo Controlled Comparison of the Effectiveness and Safety of Azelastine and Controlled Release Theophylline in the Management of Theophylline Dependent Asthmatics.

Wallace Laboratories

Cranbury, N.J.

Completed:    1989

 

 

  1. Study No. 174

Evaluation of the Steroid Sparing Effect of Azelastine in Patients Who Use Inhaled Steroids for Management of Bronchial Asthma.

Wallace Laboratories

Cranbury, N.J.

Completed:    1989

 

  1. Study No. S87-057-13

Open-Label, Multi-Investigator Clinical Evaluation of Uni-Dur, a Twenty-Four Hour Theophylline Sustained Release Tablet.

Schering Corporation

Kenilworth, N.J.

Completed:    1988

 

  1. Study No. M88-202

A Multi-Center, Double-Blind, Randomized, Comparative Study of the Efficacy and Safety of Temofloxacin 600 mg BID and Ampicillin 500 mg QID in the Treatment of Lower Respiratory Tract Bacterial Infections.

Abbott Labs

Abbott Park, IL

Completed:    1989

 

  1. Study No. 066-108

Azithromycin in the Treatment of Streptococcal Pharyngitis in Outpatients. A Multi-Center Third Party Blinded Trial Employing Penicillin V (V-Cillin K) as a Comparative Agent.

Pfizer Labs

Groton, CT

Completed:    March 1990

 

  1. Immunetech ASM-1-05-988

Safety and Tolerance and Efficacy Study of Inhaled Pentagetide in Blocking Allergen Bronchial Challenge.

Immunetech

La Jolla, CA

Completed:    1989

 

  1. Rorer WHR-5029-116

A Double Blind Placebo Controlled Parallel Group Multiple Dose Study of WHR-5029 on Hypothalamic Pituitary Adrenal Axis Function.

Rorer

Ft. Washington, PA

Completed:    February 1990

 

  1. Bristol Meyers CN1O2-003-006

Long Term Safety of Transnasal Butorphanol in Patients with Chronic Pain of Nonmalignant Origin.

Bristol Meyers

Completed:    December 1990

 

  1. 3M-4

A Comparison of a Multiple Allergen Well to an Individual Allergen Miniscreen to Predict IgE Airborne Allergy.

3M Diagnostics Systems

Santa Clara, Ca.

Completed:    1989

 

  1. Pzifer 066-110

Azithromycin in the Treatment of Skin and Skin Structure Infections. A Multicenter 3rd Party Blinded Trial Exploring Keflex as a Comparative Agent.

Groton, CT

Completed:    April 1990

 

  1. Pzifer 066-113

Azithromycin in the Treatment of Acute Sinusitis. A Multicenter 3rd Party Blinded Trial Exploring Amoxicillin as a Comparative Agent.

Pfizer

Groton, CT

Completed:    April 1990

 

  1. Eli Lilly B9U-MC-AZAE

LY163892 vs. Augmentin in Bronchitis.

Completed:    October 1990

 

  1. Eli Lilly B9U-MC-AZAK

LY163892 vs. Augmentin in Pneumonia.

Completed:    October 1990

 

  1. Rorer WHR-5029-118

A randomized, double-blind, placebo controlled double dummy, clinical study comparing the efficacy of Intranasal Triamcinolone Acetonide spray (Nasacort) and Bioequivalent doses of Intramuscular Triamcinolone Acetonide (Kenalog 40) in patients with seasonal rhinitis.

Rorer Central Research

Horsham, PA

Completed June 1990

 

  1. Wallace 251

A double-blind, placebo controlled, randomized, parallel group study of the safety and

efficacy of azelastine and albuterol sulfate (Proventil Repetabs) in subjects with chronic

asthma.

Wallace Laboratories

Cranbury, New Jersey

Completed June 1991

 

 

 

  1. Rorer WHR-5029-503

A comparison of once daily Nasacort (Triamcinolone Acetonide) and twice daily Nasalide

(Flunisolide) in patients with perennial allergic rhinitis.

Rorer Central Research

Horsham, PA

Completed September 1990

 

  1. Merrel Dow 9918-3-C-162

A double-blind, randomized, placebo controlled parallel study comparing safety and

Efficacy of Terfenadine 120 mg qid to hydroxyzine 25 mg qid administered for 12 weeks

In the treatment of chronic idiopathic urticaria.

Merrel Dow

Cincinnati, OH

Completed June 1992

 

  1. Pfizer 6C475-C0602

The efficacy and safety of oxymethozaline HCL 0.025% zinc sulfate 0.25% vs

oxymetizaline HCL vs zinc sulfate 0.25% vs placebo vehicle in subjects with allergic

conjunctivitis.

Pfizer, Inc.

Groton, CT

SDRA

San Diego, CA

Completed August 1990

 

  1. E.P.C.C.R. #1

The effects of suggestion on the secondary immune response.

El Paso Institute for Medical Research and Development

El Paso, TX

Completed November 1989

 

  1. E.P.C.C.R. #2

A pilot study evaluating intravenous immunoglobulin as a basis for the therapy of male

infertility caused by antisperm antibodies

El Paso Institute for Medical Research and Development

Sandoz Pharmaceuticals

El Paso, TX

Completed June 1991

 

  1. E.P.C.C.R. #3

A double blind placebo controlled evaluation of Intravenous Immunoglobulin in the therapy of chronic fatigue syndrome

Supported in part by Cutter

Completed:    December 1990

 

  1. E.P.C.C.R. #4

Study of Conditioning Effect during Allergen Immunotherapy on the Immune Response

3M Diagnostics

Completed:    December 1990

 

 

 

 

  1. Abbott M90-483

Research Triangle Institute

A Multicenter, Double-blind, Randomized, Comparative Study of the Efficacy and Safety of Temafloxacin 600 mg BID and Ceclor 500 mg Q8h in the Treatment of Patients with Bacterial Infection of the Lower Respiratory Tract.

Abbott

Abbot Park, IL

Completed:    July 1991

 

  1. Eli Lilly B9U-MC-AZBJ

Pharmaco

Loracarbef vs. Amoxicillin in Acute Bronchitis

Completed:    July 1991

 

  1. Eli Lilly B9U -MC-AQAB

D.R.A.C.

Disithromycin vs. Erythromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis and Pneumonia.

Completed:    January 1991

 

  1. Upjohn M/1140/0045

Comparison of Oral Cefadoximine Praxetil (Doxef tablets) with Oral

Amoxicillin/Clavunate (Augmentin) in the Treatment of Acute Maxillary Sinusitis in Adults

The Upjohn Company

Kalamazoo, MI

Completed:    December 1991

 

  1. Abbott M90-435

P.A.C.T.

Clarithromycin vs. Cefaclor in Acute Exacerbation of Chronic Bronchitis

Abbott Laboratories

Abbott Park, IL

Completed:    July 1991

 

  1. Rhone-Poulenc-Rorer RGW-5016-112

An Efficacy Trial of Comparable Plasma Concentrations of Triamcinolone Acetonide given by inhalation (Azmacort) and Intramuscular Injection (Kenalog-40) in the Management of Moderate Asthmatics

Rhone-Poulenc-Rorer

Collegeville, PA

Completed:    October 1991

 

  1. G.D. Searle & Co. S81-89-02-053

Double-blind, placebo controlled, comparative study of the efficacy and safety of three dosage regimens of Misoprostol in the prevention of Nsaid-induced gastric ulcers.

Pharmaco

Austin, TX

Completed:    December 1991

 

 

 

 

  1. Ciba-Geigy, Inc Study 04

A double-blind, multiple dose, dose-finding trial of Formoterol suspension aerosol vs. placebo in patients with reversible obstructive airway disease.

Ciba-Geigy

Summit, NJ

Completed:    1991

 

  1. Abbott M90-483

A Multicenter, double-blind, randomized, comparative study of the efficacy and safety of Temafloxacin 600 mg BID and Ceclor 500 mg QIB in the treatment of patients with bacterial infection of the lower respiratory tract. RTI Research Triangle Park, NC

Completed:    June 1991

 

  1. Pfizer, Inc. Study 134-103-507

The effect of CP-85,958 on a specific antigen, inhalation challenge with patients with bronchial asthma.

Pfizer, Inc.

Groton, CT 06340

Completed:    Jan 1993

 

  1. The Upjohn Company Study M/1140/0045

The Study of Cefpodoxime in the Treatment of Acute Maxillary Sinusitis.

The Upjohn Company

Kalamazoo, MI

Completed:    Jan 1993

 

  1. Schering

Proventil Repetabs in the Prevention of Nocturnal Asthma.

Schering, Inc.

Kenilworth, NJ

Completed:    Nov 1992

 

  1. Broncorp, Inc

A Double Blind Placebo Controlled Study to Evaluate Low Dose Parenteral Cyanocobalmin in Lowering Total Serum IgE Levels and Decreasing Symptoms of Allergic Rhinitis

Broncorp, Inc

Trout Lake, WA

Completed:    Sept 1993

 

  1. Roberts Pharmaceuticals Study 30, 722-301 B

A Double Blind Phase III Evaluation of Doxofylline, Theophylline, and Placebo in Patients with Chronic Reversible Asthma.

Roberts Pharmaceutical Corp.

Eatontown, NJ

Completed:    Nov 1994

 

  1. Astra USA Study RPM 2439

Randomized, Open-Label Comparative Study of Rhinocort

(Budesonide) Nasal Inhaler

Completed:    Aug 1994

 

  1. Abbott Laboratories Study M94-199

Long Term surveillance Study of Zileuton Plus Usual Care versus Usual Care in Patients with Asthma.

Paragon Biomedical

Abbott Laboratories

Abbott Park, IL

Completed:    February 1997

 

  1. Abbott Laboratories Study M94-184

Comparative Cost Effectiveness Study of Clarithromycin, Erythromycin Stearate and Cefaclor in the Treatment of Lower Respiratory Tract Infections

PACT

Abbott Laboratories

Abbott Park, IL

Completed:    January 1995

 

  1. Smith Kline Beecham Study 205312/012

A Multicenter, Double Blind, Placebo Controlled, Parallel Group Comparison of Safety and Efficacy or Oral Twice Daily Administration of SB 205312 with Inhaled Tilade in Patients with Mild to Moderate Asthma.

SmithKline Beecham Pharmaceuticals

King of Prussia, PA

Completed December 1995

 

  1. The Upjohn Company Study M/1140/108

Oral Cefpodoxime Proxetil (VANTIN) Tablets In the Treatment of Acute Maxillary Sinusitis in Adults: Sinus Aspiration Study

The Upjohn Company

Kalamazoo, MI

Completed:    May 1997

 

  1. Pfizer Central Research Study 167-102

Phase II Multicenter, Randomized, Double Blind, Placebo

Controlled, Parallel Group Study of the Efficacy and Safety of Six Weeks Treatment with Oral 0-11,974 in Adults with Mild to Moderate Asthma.

Pfizer Central Research

Groton, CT

Completed January 1996

 

  1. Rhone-Poulenc-Rorer Study RG 5016T 203

A Double Blind, Dose Ranging Study of Azmacort HFA-134a

Oral Inhaler Compared to Azmacort Oral Inhaler in the Treatment of Asthma in Children

Rhone-Poulenc-Rorer

Collegeville, PA

Completed 1996

 

  1. Rhone-Poulenc-Rorer Study RG 5016T 303

A Long Term Safety Study of Azmacort HFA-134a and

Azmacort Forte HFA-134a Oral Inhaler in the Treatment of Adult Asthmatics

Rhone-Poulenc-Rorer

Collegeville, PA

Completed:    1996

 

  1. SmithKline Beecham Pharmaceuticals Study 205312/084

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to evaluate the Safety and Efficacy of Oral Twice-Daily Administration of SB 205312 in Pediatric Patients with Mild to Moderate Asthma

SmithKline Beecham Pharmaceuticals

King of Prussia, PA

Completed:    May 1996

 

  1. SmithKline Beecham Pharmaceuticals Study 205312/087

A Multi-Center, Open Label, Long-Term Study of the Safety, tolerability, and Efficacy of Oral SB 205312 in Pediatric Patients with Mild to Moderate Asthma.

ClinTrials Research, Inc.

King of Prussia, PA

Completed:    May 1997

 

  1. SmithKline Beecham Pharmaceuticals Study SB 2053 12/080

A Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Study to Examine the Effects of Oral SB 205312 300 mg BID in Patients with Asthma and concomitant Seasonal Allergic Rhinitis a Comparison to Patients taking Vanceril 168 mcg BID and as Required Nasal Rescue Medication.

ClinTrials Research, Inc.

Collegeville, PA

Completed:    November 1996

 

  1. Abbott Laboratories-Study M95-411

Phase III Study of the Safety and Efficacy of Abt-761 150 mg, 300 mg, QD VS Placebo in Moderate Asthma.

Paragon Biomedical

Abbott Park, IL

Completed:    January 1996

 

  1. Abbott Laboratories – Study M96-452

Phase III Study of ABT-761 in Patients Completing Protocol M95-411.

Paragon Biomedical

Abbott Park, IL

Completed:    January 1996

 

  1. SmithKline Beecham Pharmaceutical Study SB 205312/070

A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Two Doses of SB 205312 Administered as an Oral Suspension (75 mg BID and 150 mg BID) for 12 weeks in Pediatric Out-Patients with Asthma.

ClinTrials Research Collegeville, PA

Completed:    July 1997

 

  1. Abbott Laboratories – Study M95-337

Phase III Study of the Efficacy of Zileuton 1200 mg BID, Controlled Release (CR), and 600 mg QID, Immediate Release (IR), and Placebo in Patients with Moderate Asthma.

Covance

Abbott Park, IL

Completed:    August 1997

 

 

  1. Hoechst Marion Roussel Fexofenadine Study

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Study Comparing the Efficacy and Safety of Four Dosage Strengths of Fexofenadine HCI (20, 60, 120, & 240 mg BID) in the Treatment of Chronic Idiopathic Urticaria.

Paragon Biomedical

Kansas City, MO

Completed:    June 1997

 

  1. Abbott Laboratories — Study M97-680

A Study of the Genetic Component of ALT Elevations in Patients Previously Treated with Zileuton (Zyflo).

Abbott Laboratories

Abbott Park, IL

Completed:    September 1997

 

  1. Glaxo-Wellcome, Inc. — Study NAXA 3002

A Double-BIind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of Inhaled Zanamivir (GG167) 10 mg Administered Twice a Day for Five Days in the Treatment of Symptomatic Influenza A and B Viral Infections in Adolescents and Adults.

Glaxo Wellcome, Inc.

Research Triangle Park, NC

Completed:    March 1998

 

  1. Abbott Laboratories – Study M97-754

A Comparative Study of the Efficacy and Safety of Clarithromycin Extended Release Tablets and Loracarbef Pulvules for the Treatment of Subjects with Secondary Bacterial Infections of Acute Bronchitis.

Abbott Laboratories

Abbott Park, IL

Completed — December 1998

 

  1. Abbott Laboratories – Study M97-756

A Comparative Study of the Efficacy and Safety of Clarithromycin Extended Release Tablets and Clarithromycin Immediate Release Tablets for the Treatment of Subjects with Acute Exacerbation of Chronic Bronchitis.

Abbott Laboratories

Abbott Park, IL

Completed – March 1999

 

  1. Rhone-Poulenc Rorer — Study RGSO16Y-204

A Phase Il/Ill Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Efficacy, Safety and Dose Response Study of Azmacort (triamcinolone acetonide) HFA-134a Inhalation Aerosol 225 mcg, 450 mcg, and 900 mcg Administered Once Daily for 12 Weeks in the Treatment of Mild Persistent and Moderate Persistent Asthma in 800 Adolescents and Adults.

Paragon Biomedical

Abbott Park, IL

Completed — October 1998

 

 

 

 

  1. Wallace Laboratories — Study 368

A Randomized, Double-Blind Study of Astelin Nasal Spray Monotherapy versus Combination Therapy of A Nasal Steroid and Oral Antihistamine in Subjects with Seasonal Allergic Rhinitis.

Wallace Laboratories

Cranbury, NJ

Completed – June 1998

 

  1. TAP Holdings, Inc. — Study CEF-97-006

Comparative Safety and Efficacy of Cefditoren Pivoxil and

AmoxIcillin/Clavulanate (Augmentin) In the Treatment of Community-Acquired Pneumonia.

Paragon Biomedical

Deerfield, IL

Completed February 2000

 

  1. Schering-Plough — Study P97-293

A Double-Blind Placebo-controlled Study to Evaluate the Effects of Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects with Co-morbid Asthma and a History of Seasonal Exacerbations of Asthma on Medical Resources Utilization (for Asthma and SAR)

Integrated Therapeutics Group, Inc.

CRO-BCRI

Kenilworth, New Jersey

Completed —January 1999

 

  1. Bayer Pharmaceutical — Study 100161

Prospective, Randomized, Double-Blind, Comparison of the Safety and Efficacy of Oral Moxifloxacin (BAY 12-8039) 400 mg QD for 10 days Versus Oral Trovafloxadn 200 mg QD for 10 days in the Treatment of Patients with Acute Bacterial Maxillary Sinusitis.

Medical & Technical Research Associates, Inc.

Natick, Massachusetts

Completed – February 1999

 

  1. Eli Lilly and Company — Study B3M-MC-AJBA

Cefaclor vs. Cefuroxime Axetil in Difficult to Treat Acute Otitis Media

PPD — Pharmaco

Wilmington, North Carolina

Completed — May 1999

 

  1. Schering-Plough — Study P00105-15

A Study to Compare the Efficacy and Safety of Claritin-D® 24 Hour Extended Release Tablets and Allegra-D® in Subjects with Seasonal Allergic Rhinitis (SAR)

Integrated Therapeutics Group, Inc.

Biopharmaceutical Research Consultants, Inc.

Ann Arbor, Michigan

Completed — May 1999

 

 

 

 

 

 

  1. Pfizer Inc. — Study 253-102

Phase IIA Multicenter, Randomized, Double-Blind, Double-Dummy, Active and Placebo-Controlled, Parallel Group, Dose-Response Study of the Efficacy, Safety, and Tolerability of six weeks Oral Dosing with 0-13,610 Compared to Montelukast and Placebo In Adults with Persistent Asthma.

Clinical Trials Management Services, Inc. Bristol, Tennessee

Completed December 1999

 

  1. Schering-Plough — Study P00217

A Double-Blind, Placebo-Controlled Study With DLC (SCH 34117) In The Treatment Of Subjects >12 Years of Age With Perennial Allergic Rhinitis.

Quintiles, Inc.

Completed January 2000

 

  1. Abbott Laboratories — Study M99-053

Evaluation of the Safety and Efficacy of Three Oral Doses of ABT-773 for the Treatment of Acute Maxillary Sinusitis.

Paragon Biomedical – Irvine, CA

Completed -. May 2000

 

  1. Abbott Laboratories – Study M99-066

A Comparative Study of the Safety, Efficacy and Effectiveness of Clarithromycin Extended-Release Tablets and Augmentin Tablets for the Treatment of Subjects With Acute Exacerbation of Chronic Bronchitis.

Paragon Biomedical — Irvine, CA

Completed — April 2000

 

  1. Schering-Plough — Protocol P00214

Efficacy and Safety of SCH 034117 in Subjects with Seasonal Allergic Rhinitis and Concurrent asthma.

Kern McNeill International

Completed -~ March 2000

 

  1. Glaxo Wellcome — Protocol FPD40009

A Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Fluticasone Propionate Inhalation Powder (250 mcg QD) and Placebo in Subjects at least 12 years of age with Chronic Asthma Currently Receiving Short Acting Beta Agonist Alone.

PharmaResearch Corporation – Wilmington, NC

Completed February 2001

 

  1. Glaxo Wellcome — Protocol SAS40021

A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100 mcg BID Via the DISKUS Inhaler Versus Oral Montelukast 10mg QD in Adolescents and Adults with Persistent Asthma.

Clinical Trial Management Services, Inc. –  Bristol, Tn.

Completed — September 2000

 

  1. Fujisawa Healthcare, Inc. — Protocol 99-0-054

An Open-Label Study to Evaluate the Safety of Topically Applied Tacrolimus Ointment for .the Treatment of Atopic Dermatitis

Completed June 2001

 

  1. Aventis Pharmaceuticals Inc.

T.A.R.G.E.T. fl “The Allegra Research on Gaining Experience Trial II”

Pharmaceutical Research Associates, Inc.

Lenexa, Kansas

Completed May 2000

 

  1. Glaxo Wellcome, Inc. — Protocol FPD 40010

A Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of

Fluticasone Propionate Inhalation Powder (250 mcg QD) and Placebo in Subjects at

Least 12 Years of Age with Chronic Asthma Currently Treated with Inhaled

Corticosteroids.

PharmaResearch Corporation

Wilmington, NC

Completed March 2001

 

  1. Schering-Plough Research Institute — Protocol P0 1997

Efficacy and Safety of Combination Loratadine/Montelukast QD vs. its Components in

the Treatment of Subjects with Seasonal Allergic Rhinitis.

Ingenex Pharmaceutical Services –

Chatham Township, NJ

Completed January 2001

 

  1. Glaxo Wellcome — Protocol FAP30007

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 12-week Trial of

Inhaled Fluticasone Propionate 88 mcg BID, 220 mcg BID and 440 mcg BID versus

Placebo in Propellant GR 106642X in Adolescent and Adult Subjects with Asthma who

are Maintained on Inhaled Corticosteroid Therapy.

Kendle, Int.

New Jersey

Completed August 2001

 

  1. Glaxo Wellcome — Protocol FAP30008

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 12-week Trial of

Inhaled Fluticasone Propionate 88 mcg BID, 220 mcg BID and 440 mcg BID versus

Placebo in Propellant GR 106642X in Adolescent and Adult Subjects with Asthma who

are Maintained on Bronchodilator Therapy

Kendle, Int.

New Jersey

Completed August 2001

 

  1. Bayer Corporation — Protocol 100288

Prospective, Randomized, Double-Blind, Three-armed, Multicenter, Comparative Trial to

Evaluate the Efficacy and Safety of Faropenem daloxate 300 mg P0 BID for 7 days vs.

Faropenem Daloxate 300mg P0 BID for 10 days vs. Cefuroxime Axetil 250 mg P0 BID for

10 days in the Treatment of Acute Bacterial Sinusitis.

MTRA, Inc. —

Natick, Massachusetts

Completed November 2001

 

 

 

 

  1. Abbott Laboratories — Protocol M00-225

Comparative Study of the Safety and Efficacy of ABT-773 150 mg QD vs. 150 mg BID for

the Treatment of Acute Bacterial Sinusitis.

The Phoenix —

Mt. Arlington, New Jersey

Completed May 2001

 

  1. Dey L.P. – Protocol DL-047

A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Multicenter

Study to Assess the Safety and Efficacy of Dey Beclomethasone Dipropionate

Monohydrate Nasal Spray 0.042% in Adolescent and Adult Patients with Seasonal

Allergic Rhinitis.

Target Research

Completed November 2001

 

  1. Aventis Pharmaceuticals – Protocol XRP1526B-322

A Phase III Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Efficacy,

Safety and Dose Response Study of Ciclesonide Metered Dose Inhaler 100

mcg/Day, 200 mcg/Day, and 400 mcg/Day (Ex-valve) Administered Once Daily for

12 weeks in the Treatment of Mild to Moderate Persistent Asthma in Adolescents

and Adults.

Quintiles – San Diego, CA

Completed April 2003

 

  1. Glaxo Wellcome – Protocol SMS40314

A Multi-Center, Randomized, Double-Blind, Double-Dummy, Parallel Group, 8

Week Comparison Of Salmeterol Xinafoate Versus Ipratropium Bromide Versus

Salmeterol Xinafoate plus Ipratropium Bromide Versus Placebo in Subject with

Chronic Obstructive Pulmonary Disease.

CTMS, Inc. – Bristol, TN

Completed – June 2002

 

  1. Schering Plough (ITGI) – Protocol P02067

A Study of the Effects of Desloratadine on the Quality of Life of Subjects with

Disordered Sleep Associated with Symptomatic Seasonal Allergic Rhinitis (SAR)

BRCI, Inc. – Dexter, Michigan

Completed October 2001

 

  1. EPIMRD, Inc. – Protocol M016455/1EO5

A Double Blind, Double Dummy, Placebo Controlled Study of the Effect of

Diphenhydramine 50 mg and Fexofenadine 180 mg on the Test of Variable

Attention (TOVA).

Completed March 2001

 

  1. EPIMRD, Inc. – Protocol AZ-415

An Evaluation of Sleep and Growth Hormone Secretion in Children with Nasal

Congestion from Allergic Rhinitis Before and After Therapy with Intranasal

Budesonide.

Completed – August 2002

 

 

  1. Genentech, Inc. – Protocol Q2195g

An Open-Label Extension Study of XolairÔ (Omalizumab) in Moderate to Severe,

Persistent Asthma Subjects who Completed Study Q2143g (ALTO)

CTMS, Inc. – Bristol, TN

Completed – July 2002

 

  1. Dey L.P. – Protocol DL-047

A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Multicenter

Study to Assess the Safety and Efficacy of Dey Beclomethasone Dipropionate

Monohydrate Nasal Spray 0.042% in Adolescent and Adult Patients with Seasonal

Allergic Rhinitis.

Target Research

Completed November 2001

 

  1. Aventis Pharmaceuticals — Protocol XRP1S26B-322

A Phase III Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Efficacy, Safety and Dose Response Study of Ciclesonide Metered Dose Inhaler 100 mcg/Day, 200 mcg/Day, and 400 mcg/Day (Ex-valve) Administered Once Daily for 12 weeks in the Treatment of Mild to Moderate Persistent Asthma in Adolescents and Adults.

Quintiles — San Diego, CA

Completed December 2002

 

  1. Aventis Pharmaceuticals — Protocol M016455A/4122

A Double-Blind, Double-Dummy, Parallel-Group, Multi-Center, Randomized, Study of Fexofenadine IICL 180 mg vs. Cetirizine HCL 10 mg in Subjects with Moderate to Severe Seasonal Allergic Rhinitis (SAR) During the Fall Allergy Season.

Aventis — Bridgewater, NJ

Completed July 2002

 

  1. Altana Byk Gulden — Protocol BY217/FK1 020

12 Weeks Treatment with 250 mcg Roflumilast Versus Placebo in Patients with Asthma.

Altana — Parsippany, NJ

Completed December 2002

 

  1. GlaxoSmithKline — Protocol 5A530022

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-week Trial Evaluating the Efficacy and Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50 mcg Once Daily Versus Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50 mcg Twice Daily Versus Placebo in Symptomatic Adolescent and Adult Subjects with Asthma that is Not Controlled on short-Acting Beta 2-Agonists Alone

PRA International — Lenexa, KS

Completed May 2003

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-323

A Phase III Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Placebo Controlled, Efficacy and Safety Study of Ciclesonide MDI 400 mcg/Day, 800 mcg/ Day (Ex-Valve) and FIovent® MDI (Fluticasone Propionate) 880 mcg/Day (Ex-Actuator) Administered twice Daily for 12-Weeks In The Treatment of Severe Persistent Asthma in Adolescents and Adults

Quintiles, San Diego, CA

Completed December 2002

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-323LT

A Multicenter, Double-Blind, Randomized, One Year, Long-Term Safety Study of Ciclesonide 400 mcg/Day to 800 mcg/Day (Ex-valve) or QVAR 320 mcg/Day to 640 mcg/Day (Ex-Actuator) Metered Dose Inhaler Administered Twice Daily For the Treatment of Severe Persistent Asthma in Adolescents and Adults.

Quintiles, Inc. – San Diego, CA

Completed November 2003

 

  1. Aventis Pharmaceuticals — Protocol RPR201745-202

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter, Pilot Efficacy and Safety Study of RPR201745 Administered by Inhalation Twice Daily for Twelve Weeks in Adults with Mild to Moderate Persistent Asthma

Kendle International — Cincinnati, OH

Completed July 2002

 

  1. Novartis Pharmaceuticals — Protocol CF0R258D2307

A Randomized, Multicenter, Placebo-Controlled Parallel Group Study of Four months Duration per patient to Evaluate the Safety and Efficacy of Treatment with 24 mcg b.i.d. and 12 mcg b.i.d. Formoterol, double-blind, and 12 mcg b.i.d. Formoterol with additional on demand Formoterol doses, open-label, in adolescent and adult patients with persistent stable asthma.

Novartis — East Hanover, NJ

Completed May 2004

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-325

A Phase III Double-Blind, Parallel Group, Multicenter, Placebo-Controlled Study of Ciclesonide MDI 800 mcg/Day and 1600 mcg/Day Administered Twice Daily for 12 Weeks to Determine the Effectiveness of Ciclesonide to Reduce Oral Corticosteroid (OCS) Use in Oral Corticosteroid-Dependent Patients with Severe Persistent Asthma.

Quintiles, Inc.

Kansas City, MO

Completed November 2002

 

 

  1. Aventis Pharmaceuticals — Protocol XRP1S26B-326

A Multicenter, Open-Label, Long-Term (1 year) Safety Study of Ciclesonide 100 mcg/Day to 400 mcg/Day (Ex-Valve) Metered Dose Inhaler Administered Once Daily For The Treatment of Mild to Moderate Persistent Asthma in Adolescents and Adults.

Quintiles, Inc.

Kansas City, MO

Completed August 2003

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-341

A Phase III Double Blind, Placebo Controlled, Parallel Group, Multicenter, Efficacy, Safety and Dose Response Study of Ciclesonide Metered Dose Inhaler 50 mcg/Day, 100 mcg/Day, and 200 mcg/Day (Ex-Valve) Administered Once Daily for 12 Weeks in the Treatment of Children with Persistent Asthma.

Quintiles, Inc. — San Diego, CA

Completed December 2002

 

 

 

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-341 LT

A Multicenter, Randomized, Open-Label, One Year Long-Term Safety Study of Ciclesonide Metered Dose Inhaler 50 mcg/Day to 200 mcg/Day (Ex-Valve) Administered Twice Daily or Fluticasone Dry Powder Inhaler (Flovent® Rotadisk®) 50 mcg or 100 mcg Administered Twice Daily For the Treatment of Children with Persistent Asthma.

Quintiles, Inc — San Diego, CA

Completed December 2003

 

  1. Aventis Pharmaceuticals — Protocol XRP1526B-343

A Phase III~ Multicenter, Double-Blind, Placebo Controlled, Non-Inferiority Study Assessing the Effects of Ciclesonide Metered Dose Inhaler 50 mcg/Day and 200 mcg/Day (Ex-Valve) Administered Once Daily on Growth in Children with Mild Persistent Asthma.

Quintiles, Inc. Kansas City, MO

Completed December 2003

 

  1. GlaxoSmithKline — Protocol FAS30030

A Randomized (2:1), Stratified, Double-Blind, Parallel-Group, Placebo-Controlled, 12-Week, Multi-Center Trial of Fluticasone Propionate HFA Inhalation Aerosol 88mcg BID versus Placebo HFA Delivered via an MDI and a Valved Holding Chamber with Facemask in Pediatric Subjects 1 to <4 Years of Age with Asthma.

Ingenix, Inc. Basking Ridge, NJ

Completed December 2003

 

  1. AstraZeneca Pharmaceuticals — Protocol SD-NEE-0003

A Randomized, Double-Blind, Parallel-Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40 mg Twice Daily Versus Placebo Twice Daily in Adult Asthmatics Treated for 4 months.

RPS, Inc. — Plymouth Meeting, PA

Completed March 2004

 

 

  1. AstraZeneca Pharmaceuticals — Protocol DX-RES-2103

An Evaluation or the effectiveness of Pulmicort Respules® (budesonide inhalation Suspension) vs. Singulair® (Montelukast sodium) in children 2-8 years old with Asthma requiring controller therapy.

Target Research Associates

Philadelphia, PA

Completed January 2005

 

  1. GlaxoSmithKline~ — Protocol SAS30021

A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 12-week Trial Evaluating  the Safety and Efficacy of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50 mcg Once Daily Versus Fluticasone Propionate DISKUS Once Dally in Placebo and Symptomatic Pediatric Subjects (4 to 11 Years)

With Asthma.

PRA International

Lenexa, KS

Completed November 2003

 

 

 

 

 

  1. AstraZeneca LP — Protocol SD-039-0716

A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort (80/4.5 mcg) versus its Mono-Products (budesonide and Formoterol) in Children (> 6 Years of Age) and Adults with Asthma — SPRUCE 80/4.5

PPD Development, Inc.

Morrisville, NC

Completed December 2003

 

  1. AstraZeneca LP — Protocol SD-039-0719

A Six-Month, Randomized, Open-Label Safety Study of Symbicort~ (160/4.5 mcg) Compared to Pulmicort Turbohaler® in Asthmatic Children Aged Six to Eleven Years –       SAPLING

PPD Development, Inc.

Morrisville, NC

Completed August 2003

 

  1. Forest Laboratories, Inc. — Protocol ANC-MD-21

An In-Use Study of the Dose Indicator for the Flunisolide HFA Inhaler System.

Forest Laboratories, Inc.

Jersey City, NJ

Completed June 2003

 

  1. Longwood Pharmaceutical-Tedor Pharma Inc.

Protocol LPR-A023-C1

A Single-Dose, Randomized, Double-Blind, Double-Dummy, 6-Period, Crossover, Placebo-Controlled, Phase I/Il, Dose-Ranging Study Comparing the Efficacy and Safety of 75, 100, and 200 mcg per Capsule of Albuterol Sulfate Dry Powder Delivered via a Dry Powder Inhaler (Flowcaps® Inhaler) and 108 and 216 mcg (ex-Actuator) of Albuterol Sulfate via Metered-Dose Inhaler in Patients with Asthma.

PPD Development, Inc.

Morrisville, NC

Completed December 2004

 

  1. Pfizer, Inc. — Protocol A00661078

A Multi-Center, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis In Adults Undergoing Diagnostic Sinus Aspiration.

RPS, Inc. — Blue Bell, PA

Completed April 2004

 

  1. Aventis Pharmaceuticals — Protocol M016455P/3002

A Multi-Centers Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study To Assess the efficacy and Safety of Fexofenadine 120 mg in Subjects with Mild to Moderate Persistent Asthma.

Quintiles, Inc.

Kansas City, MO

Completed Jun 2003

 

 

 

 

 

 

  1. Astra-Zeneca Protocol SD-004-0726

A Placebo-Controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbohaler® and the New Version of Pulmicort Turbohaler® in Asthmatic Children and Adolescents.

ICON Clinical Research

Newark, DE

Completed July 2004

 

  1. Aventis Pharmaceuticals — Protocol XRG50291/6004

The Benefit of Nasacort AQ® in Adult Subjects with Allergic Rhinitis and Suspected

Associated Sleep Breathing Disorders.

Western Sky Medical Research Grant

Completed July 2004

 

  1. Forest Research Institute — Protocol ANC-MD-17

Double Blind Study of the Efficacy, Safety, and Pharmacoeconomics of Flunisolide

HFA Inhaler System as Compared to Fluticasone Inhalation Aerosol in Patients with

Asthma.

Forest Research Institute — Jersey City, New Jersey

Completed January 2004

 

  1. Astra Zeneca Protocol SD-039-0718

A Twelve-Week, Randomized, Double-Blind, Double-Dummy Trial of Symbicort®

(40/4.5 mcg) versus its Mono-Products (budesonide and Formoterol) in Asthmatic

Children Aged Six to Fifteen Years-SEEDLINGS 40/4.5

PPD Development, Inc. — Morrisville, NC

Completed December 2003

 

  1. Altana Byk Gulden — Protocol BY217/FK1 021

12 Weeks Tr0atment with 125 mcg Roflumilast versus 250 mcg Roflumilast versus

Placebo in Patients with Asthma.

Altana Inc. — Melville, NY

Completed April 2004

 

  1. Schering—Plough — Study P03284-35

Efficacy and safety Of Desloratadine 10 mg daily versus Placebo in Subjects with

Allergic Airway~ Disease During the Pollen Season

Integrated Therapeutics Group, Inc.

Kenilworth, NJ

Completed December 2004

 

  1. Astra Zeneca Protocol SD-039-0717

A Twelve-Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled

Trial of Symbicort® (160/4.5 mcg) versus its Mono-Products (budesonide and

formoterol) in Adolescents (>12 Years of Age) and Adults with Asthma – SPRUCE

160/4.5

PPD Development

Wilmington, NC

Completed March 2004

 

 

 

 

  1. Astra Zeneca Protocol D5896C0001

A Randomized, double-blind, active-controlled, parallel-group, single-dummy,

multicenter, 12 week study to assess the efficacy and safety of Symbicort® pMDI

160/4.5 mcg x 2 actuations once-daily compared to Symbicort pMDI 80/4.5 mcg x 2

actuations QD, Symbicort pMDI 80/4.5 mcg x 2 actuations

Target Research

Philadelphia, PA

Completed January 2005

 

  1. Aventis Pharmaceuticals, Protocol AVE0547A2001

A Twelve week, randomized, double-blind, parallel group trial comparing the

efficacy, safety, and tolerability of a 20mg daily dose of IPL512, 602 oral tablets to

placebo in subjects with mild to moderate persistent asthma.

Kendle Int.

Cincinnati, OH

Completed April 2004

 

  1. GlaxoSmithKline, Protocol FLS-R28

A double-blind, randomized, controlled trial comparing the efficacy of treatment with

Fluticasone Nasal Spray to Placebo in Adult Subjects with Allergic Rhinitis and

History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness.

Western Sky Medical Research Grant

Completed July 2004

 

  1. Dey, L.P. – Protocol DL-059

A 12-week, double-blind, parallel-group, placebo and active controlled trial to evaluate

the efficacy and safety of formoterol fumerate inhalation solution 20 mcg in the

treatment of patients with chronic obstructive pulmonary disease; Followed by a

40-week open-label safety extension.

i3 Research

Cary, NC

Completed Jan 2006

 

  1. Aventis Pharmaceuticals, Protocol XRP1526B – 3027

A multi-center, multinational, randomized, double-blind, parallel group study of the

effects of Ciclesonide HFA-MDI 640 mcg/day and Beclomethasone HFA-MDI 640

mcg/day on Lens Opacification in adult subjects with moderate to severe persistent

asthma

PPD Development

Wilmington, NC

Completed August 2005

 

  1. Novartis, Protocol CLAF237A2301

A multicenter, randomized, double-blind study to compare the effects of 24 weeks

Treatment with LAF237 (50 mg qd, 50 mg bid or 100 mg qd) to placebo in drug

Naïve patients with type 2 diabetes.

Novartis

East Hanover, NJ

Completed May 2006

 

 

 

 

 

  1. GlaxoSmithKline, Protocol P2200314

A Safety Study of a Topical Corticosteroid Cream in Pediatric Subjects Aged 3 Months to

35 months with Atopic Dermatitis.

Bailer Pharma

Overland Park, KS

Completed January 2005

 

  1. GlaxoSmithKline, Protocol P2200313

A Safety Study of a Topical Corticosteroid Cream in Pediatric Subjects Aged 3 years to

5 years 11 months with Atopic Dermatitis

Bailer Pharma

Overland Park, KS

Completed January 2005

 

  1. Novartis, Protocol CLAF237A2301 E1

A 28-week extension to a multicenter, randomized, double-blind study to compare the

effects of 24 weeks treatment with LAF237 (50mg qd, 50 mg bid, or 100 mg qd) to placebo

in drug naïve patients with type 2 diabetes

Novartis Pharmaceutical

East Hanover, NJ

Completed May 2006

 

  1. Novartis, Protocol CSPP100A2307

An eight week, randomized, double-blind, parallel group, multicenter, dose escalation study

to evaluate the efficacy and safety of aliskiren administered alone and in combination with

ramipril in patients with hypertension and diabetes mellitus.

Novartis Pharmaceuticals

East Hanover, NJ

Completed Nov 2005

 

  1. Novartis, Protocol CLAF237A2355

A multicenter, randomized, double-blind, active controlled study to compare the effect of 24

weeks treatment with combination therapy of LAF237 and Pioglitazone to LAF237

monotherapy or Pioglitazone monotherapy in drug naïve patients with type 2 diabetes.

Novartis Pharmaceuticals

East Hanover, NJ

Completed Feb 2006

 

  1. GlaxoSmithKline, Protocol SFA100062

A randomized, parallel group, double-blind, comparative trial assessing lung function and o

other measures of asthma control in adults and adolescents, at least 12 years of age, with

persistent asthma, who have either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly

genotype and are treated with fluticasone propionate/salmeterol diskus® combination

product 100/50mcg or salmeterol diskus® 50mcg BID

GlaxoSmithKline

Research Triangle Park, NC

Completed June 2006

 

 

 

 

 

 

 

  1. Sanofi-Aventis, Protocol AVE2635A/2001

A placebo and active-controlled (ciclesonide metered-dose inhaler), randomized, parallel-

Group, dose-range finding study of ciclesonide administered by a dry powder inhaler

(Ultrahaler®) in adult and adolescent patients with persistent asthma.

PPD

Morrisville, NC

Completed Oct 2005

 

  1. GlaxoSmithKline, Protocol FFR30008

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to

Evaluate the safety and efficacy of once-daily, intranasal administration of GW685698X

Aqueous nasal spray 50mcg and 100mcg for 12 weeks in pediatric subjects ages 2 to

<12 years with perennial allergic rhinitis (PAR)

GlaxoSmithKline

Research Triangle Park, NC

Completed October 2005

 

  1. GlaxoSmithKline, Protocol FFR30010

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to

Evaluate the efficacy and safety of once-daily, intranasal administration of GW685698X

Aqueous nasal spray 50mcg and 100mcg for 2 weeks in pediatric subjects ages 2 to

<12 years with seasonal allergic rhinitis (SAR)

GlaxoSmithKline

Research Triangle Park, NC

Completed Dec 2005

 

  1. Dynavax Technologies Corporation DV1-SAR-08

A Phase IIb, Double-Blind, Randomized Study of the Efficacy and Safety and Tolerability

Of Subcutaneously Administered Dynavax Amb a 1 Immunostimulatory

Oligodeoxyribonucleotide Conjugate (A1C) Plus Antihistamine and Decongestant versus

Antihistamine and Decongestant Alone in Ragweed Allergic Children.

Quintiles, Inc.

Austin, TX

Completed May 2007

 

  1. Sanofi-Aventis Protocol XRP1526B/3030

A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to

assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 mcg

administered for 12 weeks either in a once-daily regimen in the morning (160 mcg qd AM)

or in a twice-daily regimen (80 mcg bid) in adults and adolescents with mild to moderate

persistent asthma treated previously with inhaled corticosteroids.

PPD

Morrisville, NC

Completed Apr 2006

 

  1. Novartis Pharmaceuticals Corp. Protocol CLAF237A2384

A multicenter, randomized, double-blind study to compare the effects of 24 weeks

treatment with LAF 237 (50 mg qd, 50 mg bid or 100 mg qd) to placebo in drug naïve

patients with type 2 diabetes.

Novartis Pharm.

East Hanover, NJ

Completed May 2006

 

 

  1. GlaxoSmithKline, Protocol SFA100316

A stratified, multicenter, randomized, double-blind, parallel group, 4-week comparison of

fluticasone propionate/salmeterol DISKUS combination product 100/50 mcg BID versus

fluticasone propionate DISKUS 100 mcg BID in pediatric and adolescent subjects with

activity-induced bronchospasm.

GSK

RTP, NC

Completed Dec 2005

 

  1. GlaxoSmithKline, Protocol ADA103578

A multicenter, randomized, double-blind, triple-dummy, placebo-controlled, parallel group,

four-week study assessing the efficacy of fluticasone propionate aqueous nasal spray 200

mcg QD versus montelukast 10 mg QD in adolescent and adult subjects with asthma and

seasonal allergic rhinitis who are receiving Advair Diskus® 100/50 mcg BID or placebo

BID.

GSK

RTP, NC

Completed September 2007

 

  1. Centocor, Inc. – C0524T03

A phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group,

dose-ranging study evaluating the efficacy and safety of CNTO 148 administered

subcutaneously in symptomatic subjects with severe persistent asthma

Quintiles, Inc.

Kansas City, MO

Completed August 29, 2007

 

  1. Novartis Pharmaceuticals Corporation – CIGE025AUS23

A 26-week, randomized, double-blind, parallel-group, placebo-controlled, multi-center

study to evaluate the effect of Xolair (omalizumab) on improving the tolerability of specific

immunotherapy in patients with persistent allergic asthma.

Novartis

East Hanover, NJ

Completed February 19, 2008

 

  1. Aventis Pharmaceuticals, Inc. – AVE2635A/2003

A placebo and active controlled, parallel-group, dose-finding study of formoterol fumerate

given by dry powder inhalation using the Ultrahaler® in adult and adolescent patients

with persistent asthma.

PPD, Inc.

Morrisville, NC

Completed May 2006

 

  1. Sanofi-Aventis – XRP1526B-3031

A multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group

study to assess the efficacy of ciclesonide metered-dose inhaler at a daily dose of 160 mcg

administered either in a once-daily in the morning regimen (160 mcg qd AM) for 16 weeks

or in a 160 mcg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 mcg

bid) for 4 weeks, or in a 80 mcg bid regimen for 16 weeks, in adults and adolescents with

mild to moderate persistent asthma not treated with steroids.

PPD, Inc.

Morrisville, NC

Completed March 2007

 

 

  1. Novartis Pharmaceuticals Corporation – CVAH631D2301

A 6-week, multicenter, randomized, double-blind, parallel-group study to evaluate the

combination of valsartan/HCTZ (160/12.5 mg with forced titration to a maximum dose of

320/25 mg) compared to valsartan monotherapy (160 mg with forced titration to 320 mg)

as initial therapy in patients with severe hypertension.

East Hanover, NJ

Completed August 2006

 

  1. Novartis Pharmaceuticals Corporation – CSPP100A2327

An 8-week randomized, double-blind, parallel group, multi-center, placebo and active

Controlled dose escalation study to evaluate the efficacy and safety of aliskiren (150 mg

And 300 mg) administered alone and in combination with valsartan (160 mg and 320 mg) in

Patients with hypertension.

East Hanover, NJ

Completed September 2006

 

  1. Astra Zeneca – D5899C00001

A 12-month, double-blind, double-dummy, randomized, parallel group, multicenter efficacy

And safety study of SYMBICORT® pMDI 2 x 160/4.5 mcg bid and 2 x 80/4.5 mcg bid

Compared to formoterol TBH 2 x 4.5 mcg bid and placebo in patients with COPD.

Completed July 2007

 

  1. Critical Therapeutics, Inc. – CTI-04-C05-201

Assessment of safety, tolerability, and pharmacokinetics of Zileuton injection in patients

with asthma.  (Phase I/II)

Paragon Biomedical

Irvine, CA

Completed July 2006

 

  1. Morton Grove Pharmaceuticals – MGP707

A multi-center, three arm, parallel group, double blind, placebo-controlled, randomized

Study of the bioequivalence and efficacy of fluticasone propionate nasal spray (MGP)

Compared to Flonase® Nasal Spray (GlaxoSmithKline) in patients with seasonal

Allergic rhinitis.

Criterium

Saratoga Springs, NY

Completed June 2006

 

  1. Novartis Pharmaceuticals Corporation – CSPP100A2344

A 36 week randomized, double-blind, parallel group, multi-center, active-controlled,

Optional titration study comparing an aliskiren-based regimen to a lisinopril-base regimen

In patients >65 years old with systolic essential hypertension.

East Hanover, NJ

Completed June 30, 2008

 

  1. Dey, LP – 201-070

A 6-week double-blind, parallel-group, active-controlled trial to compare the efficacy and

Safety of concomitant treatment of formoterol fumarate inhalation solution 20 mcg twice

Daily and tiotropium 18 mcg once daily to tiotropium 18 mcg once daily alone in the

Treatment of patients with chronic obstructive pulmonary disease.

PRA International

Lenexa, KS

Completed January 30, 2007

 

  1. Genentech, Inc. – Q3662g

A phase IIIb multicenter, randomized, double-blind, placebo-controlled study of Xolair®

In subjects with moderate to severe persistent asthma who are inadequately controlled

With high-dose inhaled corticosteroids and long-acting beta-agonists.

Quintiles, Inc.

Kansas City, MO

Completed November 2009

 

  1. Skye Pharma – Protocol: SKY2028-3-004

A Randomized, double-blind, placebo-controlled, parallel group, stratified, multicenter,

12-week study comparing the safety and efficacy of fluticasone and formoterol combination

(FlutiForm™ 100/10mcg or 250/10mcg twice daily) in a single inhaler (SkyPharma HFA

pMDI) with the administration of placebo or fluticasone (250 mcg twice daily) and

formoterol (10mcg twice daily) alone in adolescent and adult patients with moderate to

severe asthma.

MDS Services

St. Laurent, Quebec

Completed June 19, 2008

 

  1. University of Texas at El Paso

Impulse Oscillometric Evaluation of the Effect of Air Quality on Respiratory Function in

Normal and Asthmatic Anglo and Hispanic children on the U.S.-Mexico Border

El Paso, TX

Completed December 2008

 

  1. Genentech Protocol: Q2982g

A prospective, randomized, double-blind study of the efficacy of Xolair® in atopic                           asthmatics with good lung capacity who remain difficult to treat. (EXACT)

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080-4990 USA

Completed February 2011

 

  1. Merck & Co., Inc Protocol: 336-00

A multicenter, double-blind, placebo controlled, randomized, parallel-group study to                        evaluate the clinical effect of oral Montelukast versus placebo in persistent asthma which

is also active during allergy seasons in pediatric patients with seasonal aeroallergen                               sensitivity.

Merck & Co

Completed August 2007

 

  1. SkyPharma Protocol: Sky2028-3-002

A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-            Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol                              Combination (FlutiForm™ 100/10 mcg twice daily) in a Single Inhaler (SkyePharma HFA                        pMDI) with Administration of Fluticasone (100 mcg twice daily) and Formoterol (10 mcg                           twice daily) Alone in Adolescent and Adult Patients with Mild to Moderate Asthma.

MDS Services

St. Laurent, Quebec

Completed April 17, 2008

 

 

 

  1. Sanofi Aventis Protocol: EFC6695

A multicenter, multi-national, randomized, double-blind, placebo-controlled, study to assess          the efficacy and safety of Ciclesonide metered-dose inhaler at 80 mcg BID or 40 mcg BID                 for 12 weeks in patients aged 4 to <12 years with persistent asthma.

Omnicare

630 Allendale Road

King of Prussia, PA 19406

Completed April 2008

 

  1. AstraZeneca Protocol: D5896C00021

A 12-Week, randomized, double-blind, active-controlled, multi-center, phase IIIB study                    comparing the efficacy and evaluating the safety of SYMBICORT® pMDI 160/4.5 mcg x 2           actuations twice daily versus budesonide HFA pMDI 160 mcg x 2 actuations twice daily in          adult and adolescents (>12 years) Hispanic subjects with asthma

Parexel International Corporation

5870 Trinity Parkway, Suite 600

Centreville, VA 20120

Completed May 2008

 

  1. Genentech Inc. Protocol: Q2948g

An epidemiologic study of Xolair® (omalizumab): Evaluating clinical effectiveness and long-       term safety in patients with moderated to severe asthma (EXCELS)

Genentech, Inc

1 DNA Way

South San Francisco, CA 94080-4990 USA

Ongoing

 

  1. Novartis Protocol: LAF237A23119

A multi-center, randomized, open-label, active controlled, parallel arm study to compare the           efficacy of 12 weeks of treatment with Vildagliptin 100 mg, qd to thiazolidinedione (TZD) as       add-on therapy in patients with Type II Diabetes inadequately controlled with metformin              monotherapy in a community-based practice setting.

i3 Research

Completed November 2007

 

  1. ALCON Protocol: C-05-69

Safety Study of Olopatadine Nasal Spray

Alcon Labs

Completed January 2008

 

  1. MedPointe Protocol: MP435

A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-          36 in Patients with Perennial Allergic Rhinitis

i3 Research

Completed July 2007

 

  1. Novartis Protocol: CVEA489A2302

An 8-week, multicenter, randomized, double-blind, parallel-group study to evaluate the                   efficacy and safety of the combination valsartan/HCTZ/amlodipine compared to                            valsartan/HCTZ, valsartan/amlodipine, and  HCTZ/amlodipine in patients with moderate to        severe hypertension.

Novartis

Completed October 2007

 

 

  1. Novartis Protocol: CLMF237A2302

A randomized, double-blind, controlled, multicenter study to compare the effect of 24                      weeks treatment with a fixed combination therapy of vildagliptin and metformin to the                  individual monotherapy components in drug naïve patients with Type 2 Diabetes

Novartis

Completed July 2008

 

  1. GlaxoSmithKline Protocol: ADA103575

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel                   Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal      Spray 200 mcg QD versus Montelukast 10 mg QD in Adolescents and Adult Subjects with         Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS®100/50 mcg       BID or Placebo BID

GlaxoSmithKline

Completed February 2007

 

  1. Merck & Co., Inc Protocol: 301-02

A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of                                   Intravenous Montelukast with Placebo in Pediatric Patients (ages 6 to 14 years) with Acute           Asthma

PRA International

Completed July 2007

 

  1. Eli Lilly and Company Protocol: H7U-MC-IDAS

A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin          Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients with Diabetes and              COPD or Asthma

Quintiles

Completed November 2007

 

  1. Astra Zeneca: Protocol D5896C00025

A two-week, randomized, double-blind study assessing the onset of effect questionnaire

(OEQ) administered pre-dose versus post-dose in adult subjects (≥ 18 years of age) with

mild to moderate asthma, receiving SYMBICORT® pMDI 80/4.5 mcg x 2 actuations twice

daily or Budesonide HFA pMDI 80 mcg x 2 actuations twice daily.

Parexel

Completed February 2008

 

  1. Amgen, Inc.: Protocol 20060161

A randomized, double-blind, placebo-controlled, multiple dose phase 2 study to determine

The safety and efficacy of AMG 317 in subjects with moderate to severe asthma.

RPS

Completed December 2008

 

  1. Critical Therapeutics, Inc.: Protocol CTI-03-C07-401

A randomized, double-blind, placebo-controlled study to evaluate the efficacy of Zileuton

Controlled-Release (CR) tablets versus placebo in adult patients with asthma poorly

Controlled on moderate dose inhaled corticosteroids (ICS).

Clinquest

Completed July 2008

 

 

 

 

  1. Critical Therapeutics, Inc.: Protocol CTI-04-C07-202

Assessment of pulmonary function, safety, tolerability, and pharmacokinetics (PK) of

Zileuton injection in patients with chronic stable asthma.

Clinquest

Completed May 2008

 

  1. Med Pointe Pharmaceuticals: Protocol MP439

Randomized, double-blind, placebo-controlled trial of the safety and efficacy of MP03-36

In patients with seasonal allergic rhinitis.

Omnicare

Completed January 2008

 

  1. Schering Plough Research Institute: Protocol P04334

A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/

Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate

And Formoterol Monotherapy in Subjects with Persistent Asthma Previously Treated

With Medium-Dose Inhaled Glucocorticosteroids

Quintiles

Completed November 2008

 

  1. Schering Plough Research Institute: Protocol P04073

A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/

Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate

And Formoterol Monotherapy in Subjects with Persistent Asthma Previously Treated

With Low-Dose Inhaled Glucocorticosteroids

Quintiles

Completed November 2008

 

  1. Med Pointe Pharmaceuticals: Protocol MP436

Active-Controlled Trial of the Safety and Tolerability of MP03-36 in Patients with

Perennial Allergic Rhinitis

i3 Research

Completed September 2008

 

  1. GlaxoSmithKline: Protocol FFU105924

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week,

Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal

Spray Characteristics of Once-Daily, Intranasal Administration of 110 mcg Fluticasone

Furoate Nasal Spray and 200 mcg Fluticasone Propionate Nasal Spray in Adults Subjects

With Seasonal Allergic Rhinitis

GlaxoSmithKline

Completed November 2007

 

  1. GlaxoSmithKline: Protocol ADA109057

A Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol

DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP)

DISKUS 250 mcg BID in Treatment of Subjects with Asthma

GlaxoSmithKline

Completed March 2009

 

 

 

 

 

  1. Novartis Protocol: CQAB149B2335S

A 26-week treatment, multicenter, randomized, double-blind, double dummy, placebo-                    controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and                 tolerability of two doses of Indacaterol (selected from 75, 150, 300 & 600 ug o.d.) in                      patients with chronic obstructive pulmonary disease using blinded Formoterol 912ug b.i.d)           and open label Tiotropium (18 ug o.d.) as active controls.

Novartis

Completed September 2008

 

  1. Novartis Protocol: CQAB149B2346

A 12-week treatment, multi-center, randomized, double-blind, placebo controlled, parallel              group study to assess the efficacy and safety of Indacaterol (150 mg o.d.) in patients with                       chronic obstructive pulmonary disease.

Novartis

Completed September 2008

 

  1. GlaxoSmithKline Protocol: FFR101782

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to              Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110 mcg                       QD on Growth in Pre-Pubescent, Pediatric Subjects with Perennial Allergic Rhinitis

GlaxoSmithKline

Completed February 2011

 

  1. AstraZeneca: Protocol D525BC00007

A 2 x 1-week, cross-over, multicenter, randomized trial to evaluate the functionality

Of and electronic nebulizer (eFlow®) for use by parents/caregivers on asthmatic or

Wheezing children

Omnicare

Completed August 2008

 

  1. UCB: Protocol RPCE07K2412 (A00430)

A multi-center, randomized, double-blind, placebo-controlled, parallel-group study

evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg                 once daily given for 2 weeks in subjects 18 years of age and older with seasonal allergic                        rhinitis.

Clinsys

Completed August 2008

 

  1. Ception Protocol: RES-5-0010

An Efficacy and Safety Study of Reslizumab (CTX55700) in the Treatment of Poorly                       Controlled Asthma in Subjects with Eosinophilic Airway Inflammation

Premier Research

Completed December 2008

 

  1. Novartis Protocol: CQAB149B2335SE

A 26-week extension to a 26-week treatment, multicenter, randomized, double-blind,                       placebo-controlled, adaptive, seamless, parallel-group study to assess safety, tolerability                        and efficacy of two doses of indacaterol (150 and 300 ug o.d.) in patients with chronic                obstructive pulmonary disease

Novartis

Completed March 2009

 

 

 

  1. SkyePharma Protocol: SKY2028-1-003

A Randomized, Double-blind, Placebo-and Active-Controlled, Parallel Group, 6-week Study         to Evaluate the Effect of Multiple Doses of FlutiForm 250-10 ug HFA pMDI twice daily,                    FlutiForm 100/10 ug HFA pMDI twice daily, Prednisone and Placebo on the Hypothalamic-            Pituitary-Adrenal Axis in Adult Subjects with Mild to Moderate Asthma

Abbott

Completed October 2008

 

  1. GlaxoSmithKline Protocol: FFR110537

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year                       Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray                      110mcg in Adults and Adolescents 12 Years of Age and Older with Perennial Allergic                Rhinitis

GlaxoSmithKline

Completed February 2011

 

  1. Forest Research Institute Protocol: GRC-MD-50

Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients with Chronic

Obstructive Pulmonary Disease

Forest Research Institute

Completed 2009

 

  1. Novartis Pharmaceutical Protocol: CVAH631BUS08

A 16 week multi-center, randomized, double-blind study to evaluate efficacy and safety of

Valsartan/hydrochlorothiazide (HCTZ) combination therapy compared to patients initiated

With valsartan monotherapy or hydrochlorothiazide monotherapy in very elderly patients

With essential hypertension.

Premier Research

Completed 2009

 

  1. Phenomix Corporation Protocol: PHX1149-PROT301

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to

Evaluate Safety and Efficacy of Dutogliptin/PHX1149T as Monotherapy in Subjects with

Type 2 Diabetes Mellitus

MDS Pharma Services

Completed 2009

 

  1. Phenomix Corporation Protocol: PHX1149-PROT300E

An open label, multi-center, long-term extension study to evaluate the safety of Dutogliptin

PHX1149T in subjects with type 2 diabetes mellitus.

MDS Pharma Services

Completed July 2010

 

  1. Novartis Pharmaceutical Corporation Protocol: CLAF237B2201

A multi-center, randomized, double-blind study to evaluate the efficacy and long-term

safety of vildagliptin modified release (MR) as monotherapy in patients with type 2

diabetes.

Novartis Pharmaceutical Corporation

Completed 2009

 

 

 

 

 

  1. Novartis Pharmaceutical Corporation Protocol: CSPV100AUS01

An 8 week randomized, double-blind, parallel group, multi-center, active controlled study to

Evaluate the efficacy and safety of Valsartan administered in combination with Aliskiren

(160/150 mg, 320/300 mg) versus Valsartan alone (160 mg, 320 mg) in patients with

Stage 2 hypertension.

Novartis Pharmaceutical Corporation

Completed 2009

 

  1. Novartis Pharmaceutical Corporation Protocol: CLAF237B2224

A multi-center, randomized, double-blind study to evaluate the efficacy and long-term

Safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients

With type 2 diabetes.

Novartis Pharmaceutical Corporation

Completed 2009

 

  1. Novartis Pharmaceutical Corporation Protocol: CIGE025AUS33

A 26-week randomized, double-blind, placebo-controlled, multi-center study to evaluate the

Effect of omalizumab on markers of asthma impairment in patients with persistent allergic

Asthma.

Novartis Pharmaceutical Corporation

Completed 2009

 

  1. Sanofi-Aventis US Protocol: XRG5029C/3503

A randomized, multicenter, double-blind, placebo-controlled, parallel group study of the

12 month effect of treatment with once daily triamcinolone acetonide (NASACORT® AQ

Nasal Spray 110 mcg) on the growth velocity of children, 3 to 9 years of age, with perennial

Allergic rhinitis.

MDS Pharma

Completed May 2011

 

  1. Novartis Pharmaceutical Corporation Protocol: CQAB149B2349

A 12 week treatment, multi-center, randomized, parallel group, double blind, double

Dummy study to assess the superiority of indacaterol (150 mcg o.d.) via SDDPI in

Patients with moderate to severe COPD, using salmeterol (50 mcg b.i.d.) as an active

Comparator delivered via a DISKUS inhaler

Novartis Pharmaceutical Corporation

Completed 2009

 

  1. Boehringer Ingelheim Pharmaceuticals, Inc. Protocol: 1012.57

A multicenter, randomized study starting with a 4-week, 2-way crossover double-blind

Treatment phase comparing th3e efficacy and safety of Combivent® CFC MDI to albuterol

HFA MDI followed by a 4-week open-label Combivent Respimat® treatment phase when

All study drugs are used for symptom relief “as needed” in patients with moderate-to-

Severe asthma.

Boehringer Ingelheim

Completed 2009

 

  1. Western Sky Medical Research Protocol: WSMR 2008-2

A comparison of the bronchodilating activity of Symbicort pMDI 160/4.5 used in the

Conventional manner and with a valved, spacer holding chamber (Aerochamber Plus)

Astra Zeneca

Completed 2009

 

 

  1. Novartis Pharmaceutical Corporation Protocol: CQAB149B2341

A randomized, double-blind, controlled, parallel group, 12-week treatment study to

Compare the efficacy and safety of the combination of indacaterol 150 mcg once daily

With open label tiotropium 18 mcg once daily in patients with moderate to severe

Chronic obstructive pulmonary disease.

Novartis Pharmaceutical Corporation

Completed 2009

 

  1. Allergan Protocol: 192371-016-00

A multicenter, randomized, double-masked, parallel-group study evaluating the

Efficacy and safety of cyclosporine ophthalmic solution 0.010% compared with its

Vehicle administered QID for 3 months followed by a 9-month open-label phase in patients

With atopic keratoconjunctivitis.

Allergan

Completed 2010

 

  1. Sepracor Protocol: 051-359

A safety, efficacy, and tolerability study of daily dosing with levalbuterol tartrate HFA

MDI and placebo in subjects aged birth to <48 months with asthma.

Omnicare Clinical Research

Completed August 16, 2011

 

  1. Novartis Pharmaceutical Corporation Protocol: CNVA237A2303

A 52-week treatment, randomized, double-blind, placebo controlled, with open label

Tiotropium, parallel-group study to assess the efficacy, safety and tolerability of

NVA237 in patients with chronic obstructive pulmonary disease.

PPD

Completed August 2011

 

  1. Forest Research Institute Protocol A2-8432

Semi-structured interviews to explore patient perspectives of PDE4 treatment for COPD.

UBC

Completed 2009

 

  1. Forest Research Institute, Inc. Protocol: LAS-MD-35

A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of

Aclidinium Bromide At Two Dosage Levels When Administered to Patients with Moderate

To Severe, Stable Chronic Obstructive Pulmonary Disease

Forest

Completed June 2011

 

  1. AstraZeneca Protocol: D589GC00002 (Chase 2)

A Phase 2, randomized, blinded, 5-period, cross-over, placebo and active-controlled,

multicentered, dose-finding study comparing single doses of formoterol 2.25 mcg, 4.5 mcg,

And 9 mcg delivered via Symbicort pMDI and Foradil 12 mcg evaluating the relative       bronchodilating effects and safety in children with asthma who are receiving background treatment with Budesonide pMDI 160 mcg bid.

Quintiles

Completed March 21, 2012

 

 

 

 

  1. Biota Protocol: BTA798-202

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of BTA798 in

Asthmatic Adults with Symptomatic Human Rhinovirus Infection.

i3 Research

Completed April 2011

 

  1. MedImmune Protocol: MI-CP-198

A Phase 2b, Randomized study to evaluate the efficacy and safety of subcutaneous MEDI-

528 in adults with uncontrolled asthma.

MedImmune

Completed March 20, 2012

 

  1. Boehringer Ingelheim Protocol: 1268.53

A randomized, double-blind, placebo-controlled, efficacy and safety cross-over study of 4

weeks of oral BI 671800 ED 200 mg twice daily or 400 mg once daily administered in the

morning (AM) or evening (PM), in symptomatic asthma patients on inhaled Fluticasone

propionate MDI.
Boehringer Ingelheim

Completed May 2011

 

  1. Novartis Protocol: CQAB149B2357

A randomized, double-blind, double-dummy, placebo-controlled, parallel-group study to

assess the efficacy and safety of different doses of indacaterol in adult patients with

persistent asthma, using salmeterol as an active control.

Novartis

Completed July 2010

 

  1. Novartis Protocol: CQAB149B2355

A 12-week treatment, multi-center, randomized, double-blind, placebo-controlled, parallel-

group study to assess the efficacy and safety of once daily indacaterol in patients with

chronic obstructive pulmonary disease.

Novartis

Completed August 2010

 

  1. Genentech Inc. Protocol: Q4882g

A phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the

efficacy, response duration and safety of Xolair ® (omalizumab) in patients with chronic

idiopathic urticaria (CIU) who remain symptomatic despite antihistamine treatment (H1).

Quintiles

Completed September 27, 2012

 

  1. Meda Pharmaceuticals Protocol: MP411

Randomized, double-blind, placebo-controlled trial of the safety an d efficacy of MP03-36

(0.15%solution) and MP03-33 (0.10% solution) in children ages ≥6 to <12 with Perennial

Allergic Rhinitis.

Completed June 2011

 

  1. Teva Branded Pharmaceuticals Protocol: BDP-AR-305

A randomized, double-blind, placebo-controlled, parallel-group, multi-center, dose finding

study to assess the efficacy and safety of BDP HFA Nasal Aerosol in pediatric subjects (6

to 11 years of age) with seasonal allergic rhinitis (SAR)

Teva

Completed Aug 2011

 

  1. Teva Branded Pharmaceuticals Protocol: ABS-AS-306

A multi-center 52-week study to assess the safety of Albuterol Spiromax® in subjects with

Asthma.

Teva

Completed April 2011

 

  1. Teva Branded Pharmaceuticals Protocol: BDP-AR-303

A randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical study to

assess the long-term efficacy and safety of BDP HFA Nasal Aerosol (320 mcg, once daily)

in adults and adolescent subjects (12 years and older) with perennial allergic rhinitis (PAR).

Teva

Completed April 2011

 

  1. GlaxoSmithKline Protocol: HZA106839

Study administration information for a randomized, double-blind, double-dummy, active

comparator, parallel group, multicenter study to evaluate the safety of once-daily

Fluticasone Furoate/GW642444 Inhalation powder for 52 weeks in adolescents and adult

subjects with Asthma.

GSK

Completed February 2011

 

  1. Sepracor Protocol: 060-633

A 6-month randomized, double-blind, placebo-controlled, parallel group, efficacy and

safety study of once daily Ciclesonide HFA nasal aerosol (80 and 160 mcg) in the

treatment of perennial allergic rhinitis (PAR) in subjects 12 years or older.

Sepracor

Completed July 2010

 

  1. Sepracor Protocol: 060-635

A 6-month open-label, long-term safety extension study of once daily Ciclesonide HFA

Nasal Aerosol (160 mcg) in the treatment of perennial allergic rhinitis (PAR) in subjects 12

years and older.

Sepracor

Completed January 2011

 

  1. Boehringer Ingelheim Protocol: 205.416

A phase 3 randomised, double-blind, placebo-controlled, parallel-group trial to evaluate

efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (5mcg-

day) over 48 weeks as add-on controller therapy on top of usual care in patients with

severe persistent asthma.

Boehringer Ingelheim

Completed on September 2011

 

  1. Boehringer Ingelheim Protocol: 205.419

A phase 3 randomised, double-blind, placebo-controlled, parallel-group trial to evaluate

efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5

and 5 mcg once daily) compared with placebo and salmeterol HFA MDI (50 mcg twice

daily) over 24 weeks in patients with moderate persistent asthma.

Boehringer Ingelheim

Completed January 24, 2013

 

 

 

 

  1. Actelion Protocol: AC-060A202

A multi-center, double-blind, placebo-controlled, parallel-group study to establish proof-of-

concept and explore the efficacy of different doses of ACT-129968 in adult patients with

partly controlled asthma.

Actelion

Completed April 2012

  1. Boehringer Ingelheim Protocol: 1268.17

A randomized, double-blind, placebo and active controlled, parallel group study to evaluate

the safety and efficacy of 6-week treatment with oral doses of 50 mg b.i.d., 200 mg b.i.d.,

BI 671800 ED in steroid-naïve patients with persistent asthma.

Boehringer Ingelheim

Completed Aug. 2011

 

  1. Alcon Protocol: C-08-32

Safety of Patanase® Nasal Spray in Patients with Perennial Allergic Rhinitis

Alcon

Completed January 2011

 

  1. Amgen, Inc. Protocol: 20080615

A randomized, double-blind, placebo-controlled, multiple dose phase 2 study to determine

the safety and efficacy of AMG 853 in subjects with inadequately controlled asthma.

Amgen

Completed April 2011

 

  1. Amgen, Inc. Protocol: 20090203

A randomized, double-blind, placebo-controlled phase 2 study to determine the safety and

efficacy of AMG 827 in subjects with inadequately controlled asthma.

Amgen

Completed April 2012

 

  1. Sanofi-Aventis U.S. Inc., Protocol: ACT11457

A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy,

safety, and tolerability of SAR231893/REGN668 administered subcutaneously (SC) once

weekly for 12 weeks in patients with persistent moderate to severe eosinophilic asthma

who are partially controlled/uncontrolled by inhaled corticosteroids (ICS) plus long-acting

Beta 2 agonist (LABA) therapy.

Sanofi-Aventis

Completed September 2012

 

  1. Boehringer Ingelheim Protocol: 1268.16

Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to

assess the efficacy and safety of 6 weeks of oral BI671800 ED 400 mg b.i.d., Montelukast

10 mg q.d., or placebo in symptomatic asthma patients on Fluticasone propionate MDI.

Boehringer Ingelheim

Completed September 2011

 

  1. Amphastar Pharmaceuticals, Inc. Protocol: API-E004-CL-C

A randomized, double-and evaluator-blinded, active-and placebo-controlled, three-arm,

parallel, 12-week study in adolescents and adult patients with asthma.

Amphastar

Completed September 2012

 

 

  1. Cephalon Inc. Protocol C38072/3083

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the

Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma

Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma.

PPD

Completed 5/29/14

 

  1. Forest Research Institute Protocol: LAC-MD-31

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluation the Efficacy,

Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium

Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate

and Placebo for 24-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic

Obstructive Pulmonary Disease (COPD).

Forest Research Institute.

Completed May 6, 2013

 

  1. Forest Research Institute Protocol: LAC-MD-32

A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose

Combination of Aclidinium Bromide/Formoterol compared with Formoterol Fumarate in

Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

(COPD),

Forest Research Institute

Completed May 7, 2013

 

  1. Sunovion Pharmaceuticals Inc Protocol: SEP060-302

A Randomized Two Period Two-Way Crossover Study to Evaluate Patients Preference,

Statisfaction and Efficacy of a Nasal Aerosol Versus an Aqueous Nasal Spray Used for the

Treatment of Allergic Rhinitis.

PPD

Completed December 14, 2011

 

  1. Sunovion Pharmaceuticals Inc. Protocol: SEP060-308

A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety Study

of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-

Pituitary-Adrenal Axis in Subject 6-11 Years with Perennial Allergic Rhinitis.

PPD

Completed January 10, 2012

 

  1. GlaxoSmithKline Protocol:  HZA106847

A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone

Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice

Daily in Asthmatic Adolescents and Adult Subjects with Exercise-Induced

Bronchoconstriction.

GSK

Study cancelled

 

  1. Amphastar Pharmaceuticals, Inc. Protocol: API-E004-CL-D

Epinephrine Inhalation Aerosol USP, An HFA-MDI (E004): Clinical Study-D for Evaluation

of Efficacy and Safety of E004 in Children with Asthma (A Randomized, Double-Blind,

Placebo-Controlled, Two Arm, Parallel, 4-Week Study in 4-11 years old Children with

Asthma)

Amphastar Pharmaceuticals, Inc

Completed October 30, 2012

 

  1. GlaxoSmithKline Protocol: FFA115285

A randomized, double-blind, double-dummy, placebo controlled multi-centre study to

evaluate the efficacy and safety of fluticasone Furoate inhalation powder and fluticasone

propionate inhalation powder in the treatment of asthma in adults and adolescents not

currently treated with inhaled corticosteroids.

GSK

Completed October 18, 2012

 

  1. Amphastar Pharmaceuticals, Inc. Protocol: API-E004-CL-C2

A 3-Month Safety Evaluation Extension to the 12-Week E004-C Study In Asthma Patients

(A double Blinded, Placebo-Controlled, Parallel, 3-Month Safety Study in Adolescent and

Adult Patients with Asthma.

Amphastar Pharmaceuticals, Inc

Completed October 31, 2013

 

  1. Sunovion Pharmaceuticals, Inc Protocol: 060-306

A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and

Efficacy Study of Ciclesonide Nasal Aerosol in Subjeects 6-11 Years with Perennial

Allergic Rhinitis.

Sunovion Pharmaceuticals, Inc

Completed March 21, 2013

 

  1. Merck (Schering-Plough Research Institute) Protocol: P06241/P202

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety

of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus

Mometasone Furoate MDI Monotherapy in Adolescents and Adults with Persistent Asthma.

Covance

Ongoing

 

  1. Sunovion Pharmaceutical Inc, Protocol: 060-305

A 2-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and

Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6 to 11 Years with Seasonal

Allergic Rhinitis.

Sunovion Pharmaceutical Inc.

Completed May 16, 2013

 

  1. Forest Research Institute, Inc Protocol: LAC-MD-36

A Phase III, Long-Term, Randomized, Double-Blind, Extension Study of the Efficacy,

Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol

Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment

in Patients with Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

(COPD)

Forest Research Institute, Inc

Completed August 5, 2013

 

  1. Genentech (F. Hoffmann-La Roche, Ltd.) Protocol: GB27864

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy

and Safety of Lebrikizumab in Patients with Uncontrolled Asthma Who Are On Inhaled

Corticosteroids and a Second Controller Medication

Covance

Completed November 6, 2013

 

 

 

  1. Array BioPharma Protocol: 502-201

A Phase 2 Randomized, Double-Blind, Placebo-controlled, Parallel-group, Multicenter

Study to Evaluate the Efficacy and Safety of Arry-502 in Adults with Persistent Asthma

Array BioPharma

Completed July 17, 2013

 

  1. Boehringer Ingelheim Protocol: 205.444

A phase III, randomised, double blind, placebo-controlled, parallel group study to assess

the efficacy and safety over 48 weeks of orally inhaled Tiotropium bromide (2.5 µg and 5

µg once daily) delivered by the Respimat® inhaler in adolescents (12 to 17 years old) with

moderate persistent asthma.

Boehringer Ingelheim

Completed May 13, 2013

 

  1. Boehriger Ingelheim Protocol: 205.445

A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy

and safety of tiotropium inhalation solution (2.5 µg and 5 µg) delivered via Respimat®

inhaler once daily in the evening over 48 weeks in children (6 to 11 years old) with

moderate persistent asthma.

Boehriger Ingelheim

Ongoing

 

  1. Genentech (Roche) Protocol: GB 27980

A Phase IIB, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the

Efficacy, Safety and Dosing Regimens of MEMP1972A in Adults with Allergic Asthma Who

Are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller (COSTA).

Covance

Completed November 6, 2012

 

  1. Forest Research Institute Protocol:  LAC-MD-21

Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period

Complete Crossover study of the Bronchodilator Effects of Formoterol Fumarate Inhalation

Powder in Patients with Mild to Moderate Asthma.

Forest Research Institute

Completed May 8, 2013

 

  1. Rigel Pharmaceuticals, Inc. Protocol:  C-940343-004

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group

Study of Two Doses of Inhaled R940343 in Patients with Mild to Moderate Allergic

Asthma.

Rigel Pharmaceuticals, Inc.

Completed September 16, 2013

 

  1. Astra Zeneca Protocol: D589GC00001  (Chase I)

A Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter

study, comparing budesonide pMDI 160 mcg bid with placebo: a 6-week efficacy and

safety study in children aged 6 to <12 years with asthma.

Quintiles, Inc.

Completed August 14, 2013

 

 

 

 

 

  1. Boehringer Ingelheim Protocol: 1222.52

A randomized, double-blind, parallel group study to assess the efficacy and safety of 12

weeks of once daily, orally inhaled, co-administration of olodaterol 5 mcg (delivered by the

Respimat Inhaler) and tiotropium 18 mcg (delivered by the HandiHaler) compared to once

daily, orally inhaled, co-adminsitration of placebo (delivered by the HandiHaler) in patients

with Chronic Obstructive Pulmonary Disease (COPD)

Boeheringer Ingelheim

Completed January 9, 2014

 

  1. Novartis Protocol: CNVA237A2319

A multi-center, randomized, double-blind, 52-week study to assess the safety of NVA237

compared to QAB149 in patients with Chronic Obstructive Pulmonary Disease (COPD)

who have moderate to severe airflow limitation.

Novartis

Pending Close-Out

 

  1. Teva Protocol: ABS-AS-307

A multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax in Subjects

with asthma.

RPS, Inc.

Completed January 27, 2014

 

  1. GlaxoSmithKline Protocol:  HZA116863

A Randomized, Double-Blind, Parallel Group, Multicenter Study of Fluticasone Furoate/

Vilanterol 200/25 mcg Inhalation Powder, Fluticasone Furoate/Vilanterol 100/25 mcg

Inhalation Powder in the Treatment of persistent Asthma in Adults and Adolescents.

GSK

Completed November 20, 2013

 

  1. Cephalon Protocol: C38072/3085

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of

reslizumab (3.0 mg/kg) as Treatment for Patients with Eosinophilic Asthma Who

Completed a Prior Cephalon-Sponsored Study in Eosinophilic Asthma.

PPD

Pending Close Out

 

  1. Teva Protocol: FSS-AS-201

A Six-Period Crossover, Dose-Ranging Study to Evaluate the Efficacy and Safety of Four

Doses of FS Spiromax® (Fluticasone Propionate/Salmeterol Xinafoate Inhalation Powder)

Administered as Single Doses Compatred with Single Doses of Fluticasone Propionate

Spiromax and Open Label Advair Diskus in Adult and Adolescent Subjects with Persistent

Asthma

RPS, Inc

Completed July 18, 2013

 

  1. Teva Protocol: FpS-AS-202

A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fp Spiromax ®

(Fluticasone Propionate Inhalation Powder) Administered Twice Daily compared with

Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on

High dose Inhaled Corticosteroid Theapy.

PPD

Completed December 2013

 

 

  1. Novartis Pharmaceuticals Protocol: CQVA149A2336

A 12-week treatment, multi-center, randomized double-blind, parallel-group, placebo and

active controlled study to assess the efficacy, safety, and tolerability of QVA149

(indacaterol maleate/glycopyrronium bromide) in COPD patients with moderate to severe

airflow limitation.

Completed May 7, 2014

 

  1. Amgen Inc. Protocol: 20120141

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and

Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High

Bronchodilator Reversibility.

Ongoing

 

  1. Amphastar Pharmaceuticals Inc. Protocol: API-E004-CL-D2

Evaluation of Efficacy and Safety for Single Dose E004 in Children with Asthma

Completed September 24, 2013

 

  1. Boehringer Ingelheim Protocol: 1012.67

A comparison of Ipratropium Bromide and Albuterol Inhalation Spray delivered via the

Respimat Inhaler with Albuterol Sulfate HFA inhalation Aerosol and ipratropium bromide

HFA inhalation aerosol in a 4 week (28 day), multi-center, double-blind, double-dummy,

three-way, cross-over study following chronic q.i.d. administration in patients with chronic

obstructive pulmonary disease.

Study Cancelled by Sponsor

 

  1. Genentech Protocol: GB28689 (La Volta) Phase 3

A Phase III, randomized, double-blind, placebo-controlled study to assess the efficacy and

safety of Lebrikizumab in patients with uncontrolled asthma who are on inhaled

corticosteroids and a second controller medication.

Ongoing

 

  1. Mylan Protocol: MOMT-12084

A randomized, double-blind, multiple-dose trial of Mometasone Nasal Spray, 50 mcg

(Mylan), Nasonex® Nasal Spray, 50 mcg (MSD-US, Nasonex® Nasal Spray Suspension,

50 mcg (MSD-EU) and placebo for the treatment of the signs and symptoms of seasonal

allergic rhinitis in 1520 male and female volunteers.

Completed June 10, 2014

 

  1. Novartis Pharmaceuticals Inc. Protocol: CQVA149A2210

A multi-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate

the efficacy, safety and tolerability of five different doses of inhaled indacterol (QAB149)

delivered via the single dose dry powder inhaler (SDDPI) in patients with persistent

asthma.

Completed June 16, 2014

 

  1. Novartis Pharmaceuticals Inc. Protocol: CIGE025B US28

Long-term natural history of patients with severe or difficult-to-treat asthma from the

TENOR observational study.

Ongoing

 

 

 

 

 

  1. Pearl Therapeutics Inc. Protocol: PT003006

A randomized, double-blind (test products and placebo), chronic dosing (24 weeks),

placebo-controlled, parallel-group, multi-center study to assess the efficacy and safety of

PT003, PT005 and PT001 in subjects with moderate to very severe COPD, compared with

placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 mcg, open-label) as an active

control.

Completed April 2015

 

  1. Sanofi-Aventis Protocol: DRI 12544

A randomized, double-blind, placebo-controlled, dose-ranging study to evaluate dupilumab

in patients with moderate to severe, uncontrolled asthma.

Completed June 2015

 

  1. Teva Pharmaceuticals Protocol: BDP-AR-306

A randomized, double-blind, placebo-controlled, parallel-group, 12-Week, clinical study

designed to assess the efficacy and safety of BDP Nasal Aerosol (80 mcg, once daily) in

pediatric subjects (4 to 11 years of age) with Perennial allergic rhinitis (PAR).

Completed December 11, 2013

 

  1. Teva Pharmaceuticals Protocol: BDB-AS-301

A randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week

clinical study to assess the efficacy and safety of 320 or 640 mcg/day of Beclomethasone

Dipropionate delivered via breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) in

adolescent and adult patients 12 years of age and older with persistent asthma.

Completed January 6, 2015

 

  1. Teva Pharmaceuticals Protocol:  BDB-AS-304

A randomized, double-blind, placebo-controlled, parallel-group, 12-week

clinical study to assess the efficacy and safety of Beclomethasone

Dipropionate (80 and 160 mcg/day) delivered via breath-actuated inhaler (BAI) in

adolescent and adult patients 12 years of age and older with persistent asthma.

Completed May 2015

 

  1. Mylan (DEY Pharma, L.P.) Protocol: 201-085

A randomized, double-blind, placebo-controlled study to evaluate the safety of long-term

use of Perforomist ® (formoterol fumarate) inhalation solution in subjects with chronic

obstructive pulmonary disease (COPD).

Ongoing

 

  1. Pearl Therapeutics Inc. Protocol: PT008001-00

A Randomized, Double-Blind, Chronic Dosing (4weeks), Four-Period, Five-Treatment,

Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of

Four Doses of Budesonide Inhalation Aerosol (BD, MDI, PT008) Relative to Placebo MDI

in Adult Subjects With Mild to Moderate Persistent Asthma

Completed August 2015

 

  1. AstraZeneca Protocol: D589UC00001 RISE

A Phase IIIB, 6-Month, Double-Blind, Double-dummy, Randomized, Parallel-group,

Multicenter Exacerbation Study of Symbicort ® pMDI 160-4.5 ug x 2 Inhalations Twice-

Daily in COPD Patients.

Ongoing

 

 

 

  1. Teva Pharmaceuticals Protocol: FSS-AS-301

A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone

Propionate Multidose Dry Powder Inhaler Compared with Fluticasone/Salmeterol Multidose

Dry Powder Inhaler in Adolescent and Adult Patients with Persistent Asthma Symptomatic

Despite Low-Dose Inhaled Corticosteroid Therapy.

Completed September 2015

 

  1. Teva Pharmaceuticals Protocol: FSS-AS-30017

A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone

Propionate Multidose Dry Powder Inhaler Compared with Fluticasone/Salmeterol

Multidose Dry Powder Inhaler in Adolescent and Adult Patients with Persistent Asthma

Symptomatic Despite Inhaled Corticosteroid Therapy.

Completed August 2015

 

  1. Teva Pharmaceuticals Protocol: FSS-AS-305

A 26-Week Open-Label Study to Asses the Long-Term Safety of Fluticasone Propionate

Multidose Dry Powder Inhaler and Fluticasone/Salmeterol Multidose Dry Powder Inhaler in

Patients 12 Years of Age and Older with Persistent Asthma

Completed August 2015

 

  1. Perrigo Protocol PRG-NY-14-018

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study To

Demonstrate the Safety and Bioequivalence of Perrigo UK Finco’s Azelastine

Hydrochloride/Fluticasone Propionate Nasal Spray 137 mcg/50 mcg per Actuation

Compared with Meda Pharmaceuticals Inc’s Dymista® (Azelastine

Hydrochloride/Fluticasone Propionate) Nasal Spray 137 mcg/50 mcg per Actuation in the

Relief of Seasonal Allergic Rhinitis (SAR) Symptoms.

Completed May 2015

 

  1. Mylan Protocol: MGR001-3001

A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the

Local Equivalence of Multiple Doses of MGR001 to Advair® Diskus® Administered Via

Oral Inhalation in Adult Asthma Patients.

Completed August 2015

 

  1. AstraZeneca Protocol: D32SOC00032

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-controlled, Phase 3

Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients with Mild to

Moderate Persistent Asthma.

Ongoing

 

  1. AstraZeneca Protocol: D589GC00003

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group,  Multicenter Study

Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 mcg, 2 Actuations Twice

Daily, and Symbicort pMDI 80/4.5 mcg, 2 Actuations Twice Daily, Compared with

Budesonide pMDI 80 mcg, 2 Actuations Twice Daily, in Children Ages 6 to <12 years with

Asthma

Ongoing

 

 

 

 

 

 

  1. Pearl Therapeutics Inc. Protocol: PT001101-00

A Randomized, Double-Blind, Chronic-Dosing (14Days), 5-Period, 7-Treatment, Placebo-

Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the

Efficacy and Safety of PT001 Relative to Placebo MDI and Open-Label Serevent ®

Diskus® in Adult Subject with Intermittent Asthma or Mild to Moderate Persistent Asthma.

Ongoing

 

  1. Roxane Laboratories, Inc. Protocol: FLSA-P100-50-PVCL

A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence

Study of Generic Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg

Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma.

Ongoing

 

  1. Novartis Pharmaceuticals Inc. Protocol: CQVA149A2350

A multi-center, randomized, double-blind, double-dummy, active controlled, 2-period cross-

over study to assess the efficacy, safety and tolerability of indacaterol

maleate/glycopyrronium bromide compared to umeclidinium bromide/Vilanterol in COPD

patients with moderate to severe airflow limitation.

Ongoing

 

  1. Sanofi Protocol: EFC13579

A randomized, double blind, placebo-controlled, parallel group study to evaluate the

efficacy and safety of dupilumab in patients with persistent asthma.

Ongoing

 

  1. Pearl Therapeutics Inc. Protocol: PT010005-01

A Randomized, Double-Blind, Multi-Center, Parallel Group Study to Assess the Efficacy

and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52-

Week Treatment Period in Subjects with Moderate to Very Severe COPD.

Ongoing

 

  1. Teva Branded Pharmaceuticals Products R&D, Inc. Protocol: BDB-AS-30039

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study

to Assess the Efficacy and Safety of Beclomethasone Dipropionate Delivered via Breath-

Actuated Inhaler (BAI) at 320 or 640 mcg/day in Adolescents and Adult Patients 12 Years

of Age and Older with Persistent Asthma.

Ongoing

 

Updated 8/27/15