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An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
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).
Details
| Lead sponsor | Sumitomo Pharma America, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 445 |
| Start date | 2002-05 |
| Completion | 2003-01 |
Conditions
- Asthma
Interventions
- levalbuterol tartrate MDI
- racemic albuterol MDI
- Placebo
Primary outcomes
- percent change in FEV1 from visit predose averaged over the 8-week double-blind period — Weeks 0, 4, 8
Countries
United States