Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: levalbuterol tartrate MDI; Drug: racemic albuterol MDI; Drug: Placebo

• Registration Number: NCT00073827
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Detailed Description

This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Study First Submitted: 2003-12-09
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	levalbuterol tartrate MDI	levalbuterol MDI 90 mcg QID
2	racemic albuterol MDI	racemic albuterol MDI 180 mcg QID
3	Placebo	Placebo MDI QID

Primary Outcome Measures

Name	Time	Method
percent change in FEV1 from visit predose averaged over the 8-week double-blind period	Weeks 0, 4, 8

Secondary Outcome Measures

Name	Time	Method
area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period	Weeks 0, 4, 8
peak percent change in FEV1 from study baseline	Weeks 0, 4, 8
peak change in FEV1 from visit predose	Weeks 0, 4, 8
peak percent of predicted FEV1	Weeks 0, 4, 8
area under the FEV1 curve (AUC)	Weeks 0, 4, 8
peak change and peak percent change in FEF25-75% from visit predose	Weeks 0, 4, 8
peak change and peak percent change in FVC from visit predose	Weeks 0, 4, 8

Trial Locations

Locations (63)

Alabama Asthma and Allergy Center; 🇺🇸 Homewood, Alabama, United States

MDC Research; 🇺🇸 Mobile, Alabama, United States

Integrated Research Group; 🇺🇸 Corona, California, United States

Allergy & Asthma Medical Group of Diablo Valley, Inc.; 🇺🇸 Danville, California, United States

Radiant Research, Inc.; 🇺🇸 Encinitas, California, United States

Allergy & Asthma Specialists Medical Group; 🇺🇸 Huntington Beach, California, United States

Allergy, Asthma & Respiratory Care Center; 🇺🇸 Long Beach, California, United States

Allergy Research Foundation, Inc.; 🇺🇸 Los Angeles, California, United States

Clinical Trials of Orange County; 🇺🇸 Orange, California, United States

Allergy Associates Medical Group; 🇺🇸 San Diego, California, United States

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