Journal
EUROPEAN RESPIRATORY JOURNAL
Volume 51, Issue 1, Pages -Publisher
EUROPEAN RESPIRATORY SOC JOURNALS LTD
DOI: 10.1183/13993003.02053-2017
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Funding
- Bayer AG
- MRC [MR/L011263/1] Funding Source: UKRI
- Medical Research Council [MR/L011263/1] Funding Source: researchfish
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We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and predefined sputum bacteria. Patients were randomised 2: 1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in 14-or 28-day on/off treatment cycles for 48 weeks. Primary end-points were time to first exacerbation and frequency of exacerbations. Enrolling countries and a level split (0.049 and 0.001 for 14- and 28-day cycles, respectively) differed from RESPIRE 1. Patients were randomised to ciprofloxacin DPI (14 days on/off (n=176) or 28 days on/off (n=171)) or placebo (14 days on/off (n=88) or 28 days on/off (n=86)). The exacerbation rate was low across treatment arms (mean +/- SD 0.6 +/- 0.9). Active treatment showed trends to prolonged time to first exacerbation (ciprofloxacin DPI 14 days on/off: hazard ratio 0.87, 95.1% CI 0.62-1.21; p=0.3965; ciprofloxacin DPI 28 days on/off: hazard ratio 0.71, 99.9% CI 0.39-1.27; p=0.0511) and reduced frequency of exacerbations (ciprofloxacin DPI 14 days on/off: incidence rate ratio 0.83, 95.1% CI 0.59-1.17; p=0.2862; ciprofloxacin DPI 28 days on/off: incidence rate ratio 0.55, 99.9% CI 0.30-1.02; p=0.0014), although neither achieved statistical significance. Ciprofloxacin DPI was well tolerated. Trends towards clinical benefit were seen with ciprofloxacin DPI, but primary end-points were not met.
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