drugset / Trial / NCT01656811
A Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.
Timeline
- Start
- 2001-10
- Primary completion
- 2002-07
- Completion
- 2002-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levalbuterol | Other / unclassified | 90 ug | — |
| Subject | Levalbuterol | Other / unclassified | 180 ug | — |
| Comparator | racemic albuterol | Unknown | 180 ug | Inhaled |