TY - JOUR
T1 - Respire 1
T2 - A phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis
AU - De Soyza, Anthony
AU - Aksamit, Timothy
AU - Bandel, Tiemo Joerg
AU - Criollo, Margarita
AU - Stuart Elborn, J.
AU - Operschall, Elisabeth
AU - Polverino, Eva
AU - Roth, Katrin
AU - Winthrop, Kevin L.
AU - Wilson, Robert
N1 - Funding Information:
This study was supported by Bayer AG. Funding information for this article has been deposited with the Crossref Funder Registry. We thank the patients, investigators (see supplementary section S3) and study centres that contributed to RESPIRE 1. We also thank Ulrike Krahn (Bayer AG, Wuppertal, Germany) for assisting with statistical analysis, Jeff Alder (Bayer US LLC, Whippany, NJ, USA) for microbiology data assessment and critically reviewing the data, Maxine Lau (Bayer AG, Berlin, Germany) for pharmacovigilance input as well as Fusion MD (Montreal, Canada) and highfield: communication (Oxford, UK) for providing medical writing services with funding from Bayer AG. A. De Soyza, R. Wilson and J.S. Elborn acknowledge the support of EMBARC and the Medical Research Council-funded BRONCH-UK collaborative for peer support and advice in bronchiectasis.
Funding Information:
We thank the patients, investigators (see supplementary section S3) and study centres that contributed to RESPIRE 1. We also thank Ulrike Krahn (Bayer AG, Wuppertal, Germany) for assisting with statistical analysis, Jeff Alder (Bayer US LLC, Whippany, NJ, USA) for microbiology data assessment and critically reviewing the data, Maxine Lau (Bayer AG, Berlin, Germany) for pharmacovigilance input as well as Fusion MD (Montreal, Canada) and highfield: communication (Oxford, UK) for providing medical writing services with funding from Bayer AG. A. De Soyza, R. Wilson and J.S. Elborn acknowledge the support of EMBARC and the Medical Research Council-funded BRONCH-UK collaborative for peer support and advice in bronchiectasis.
Funding Information:
Support statement: This study was supported by Bayer AG. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
Copyright ©ERS 2018
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2018
Y1 - 2018
N2 - 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 bacteria in sputum. In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations. A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbation versus pooled placebo (median time >336 versus 186 days; hazard ratio 0.53, 97.5% CI 0.36–0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6 versus 1.0; incidence rate ratio 0.61, 97.5% CI 0.40–0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable. Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in noncystic fibrosis bronchiectasis.
AB - 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 bacteria in sputum. In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations. A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbation versus pooled placebo (median time >336 versus 186 days; hazard ratio 0.53, 97.5% CI 0.36–0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6 versus 1.0; incidence rate ratio 0.61, 97.5% CI 0.40–0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable. Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in noncystic fibrosis bronchiectasis.
UR - http://www.scopus.com/inward/record.url?scp=85045712871&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85045712871&partnerID=8YFLogxK
U2 - 10.1183/13993003.02052-2017
DO - 10.1183/13993003.02052-2017
M3 - Article
C2 - 29371383
AN - SCOPUS:85045712871
VL - 51
JO - The European respiratory journal
JF - The European respiratory journal
SN - 0903-1936
IS - 1
M1 - 1702052
ER -