Trials / Completed
CompletedNCT02980133
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years With Persistent Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 841 (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 to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone Propionate | Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm. |
| DRUG | Fluticasone Propionate/Salmeterol | Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm. |
| DRUG | Placebo MDPI | Matching placebo was administered via MDPI per the schedule specified in the arm. |
Timeline
- Start date
- 2016-12-28
- Primary completion
- 2019-04-07
- Completion
- 2019-04-13
- First posted
- 2016-12-02
- Last updated
- 2021-11-09
- Results posted
- 2020-03-18
Locations
118 sites across 5 countries: United States, Georgia, Hungary, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02980133. Inclusion in this directory is not an endorsement.