Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Summary
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.
Timeline
- Start
- 2013-05-02
- Primary completion
- 2016-03-09
- Completion
- 2016-03-09
Outcome
Mixed primary results
paper The primary end-points were time to first exacerbation and frequency of exacerbations. PMID 29371383 ↗
paper Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbation versus pooled placebo PMID 29371383 ↗
paper reduced the frequency of exacerbations compared with matching placebo by 39% PMID 29371383 ↗
paper Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. PMID 29371383 ↗
Publications
- De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.
- Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 32.5 mg | Inhaled |