Last reviewed · How we verify
A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
Details
| Lead sponsor | Adamis Pharmaceuticals Corporation |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2019-02 |
| Completion | 2020-04 |
Conditions
- Asthma
Interventions
- Beclomethasone 800 µg per day
- Placebo
- Beclomethasone 400 µg per day
- Beclomethasone 640 µg per day
Primary outcomes
- Change from baseline in FEV1 percent predicted compared to placebo — 6 weeks
The primary analysis of change from baseline trough (pre-dose and pre-rescue bronchodilator) FEV1 percent predicted (0-6 weeks) will be carried out on the mITT Population using analysis of covariance (ANCOVA) with treatment as an effect, and status of previous steroid use (naïve or prior use) as the covariate. The efficacy endpoint for the primary analysis is the change from baseline trough FEV1%- predicted at week 6.