drugset / Trial / NCT01437995
Long-acting Beta Agonist Step Down Study
Phase 4
Completed
459 enrolled
Johns Hopkins University
American Lung Association · collabGlaxoSmithKline · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.
Timeline
- Start
- 2012-03
- Primary completion
- 2015-09
- Completion
- 2015-10
Publications
- Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.
- DiMango E, Rogers L, Reibman J, Gerald LB, Brown M, Sugar EA, Henderson R, Holbrook JT. Risk Factors for Asthma Exacerbation and Treatment Failure in Adults and Adolescents with Well-controlled Asthma during Continuation and Step-Down Therapy. Ann Am Thorac Soc. 2018 Aug;15(8):955-961. doi: 10.1513/AnnalsATS.201711-886OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone | Other / unclassified | 100 ug | Inhaled |
| Comparator | Fluticasone | Other / unclassified | 250 ug | Inhaled |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Inhaled |