Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
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\[0-6wk\]).
Timeline
- Start
- 2015-09-30
- Primary completion
- 2016-03-31
- Completion
- 2016-03-31
Outcome
Met primary endpoint
paper BDP BAI 320 and 640 μg/day significantly improved FEV1 AUEC(0-6 wk) versus placebo (p < 0.001). PMID 29317015 ↗
registry analysis (unspecified test); Placebo vs BAI 640 mcg/Day; p <0.0001; LSM difference 150 (95% CI 86.8 to 213.2); ANCOVA; note: a priori threshold for significance of 0.05. NCT02513160 ↗
Publications
- Kerwin EM, Hickey L, Small CJ. Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone. Respir Med. 2019 May;151:35-42. doi: 10.1016/j.rmed.2019.03.010. Epub 2019 Mar 20.
- Ostrom NK, Raphael G, Tillinghast J, Hickey L, Small CJ. Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma. Allergy Asthma Proc. 2018 Mar 9;39(2):117-126. doi: 10.2500/aap.2018.39.4115. Epub 2018 Jan 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | beclomethasone dipropionate | Other / unclassified | 320 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 640 ug | Inhaled |
| Background | Salbutamol | Unknown | 90 ug | Inhaled |