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NCT02513160 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 713
- Enrollment target
NCT02513160: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02513160 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 713 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02513160, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 713 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC\[0-6wk\]).
Primary Outcome
The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, diffe
Interventions
- DRUG Placebo
- DRUG albuterol/salbutamol
- DRUG Beclomethasone Dipropionate 640
- DRUG Beclomethasone dipropionate via 320 mcg BAI
- DRUG Beclomethasone dipropionate via 320 mcg MDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2015-09-30 |
| Est. Completion | 2016-03-31 |
| Phase | Phase 3 |
What the finished NCT02513160 record still lists
NCT02513160 is an interventional study that assigns participants to a tested intervention. The registered 713 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02513160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02513160 about?
NCT02513160 is a clinical study titled "Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma". The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standard...
What is the current status of trial NCT02513160?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 713 participants. The study started on 2015-09-30. Estimated completion is 2016-03-31.
What interventions are being tested in trial NCT02513160?
The interventions under investigation include: Placebo (DRUG), albuterol/salbutamol (DRUG), Beclomethasone Dipropionate 640 (DRUG), Beclomethasone dipropionate via 320 mcg BAI (DRUG), Beclomethasone dipropionate via 320 mcg MDI (DRUG).
Who is sponsoring clinical trial NCT02513160?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02513160's enrollment target sits among peer trials
713 499th of 2000 higher than 1,502 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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