Trials / Completed
CompletedNCT00308685
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Albuterol | Albuterol 90mcg |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2006-06-10
- Primary completion
- 2006-12-04
- Completion
- 2006-12-04
- First posted
- 2006-03-30
- Last updated
- 2022-04-01
- Results posted
- 2022-02-24
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00308685. Inclusion in this directory is not an endorsement.