Trials / Completed
CompletedNCT02126839
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
A Three-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler (MDPI) Relative to Placebo in Pediatric Asthmatics
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Albuterol MDPI | 90 mcg/actuation of the multidose dry powder inhaler (MDPI). |
| DRUG | Placebo | Matching Placebo delivered via a multidose dry powder inhaler (MDPI). |
| DRUG | ProAir HFA inhaler | Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2014-04-30
- Last updated
- 2021-11-09
- Results posted
- 2016-02-05
Locations
52 sites across 2 countries: United States, Thailand
Source: ClinicalTrials.gov record NCT02126839. Inclusion in this directory is not an endorsement.