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RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis

Timothy Aksamit, Anthony De Soyza, Tiemo-Joerg Bandel, Margarita Criollo, J. Stuart Elborn, Elisabeth Operschall, Eva Polverino, Katrin Roth, Kevin L. Winthrop, Robert Wilson
European Respiratory Journal 2018 51: 1702053; DOI: 10.1183/13993003.02053-2017
Timothy Aksamit
1Mayo Clinic, Rochester, MN, USA
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  • For correspondence: aksamit.timothy@mayo.edu
Anthony De Soyza
2Newcastle University and Freeman Hospital, Newcastle upon Tyne, UK
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  • ORCID record for Anthony De Soyza
Tiemo-Joerg Bandel
3Bayer AG, Wuppertal, Germany
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Margarita Criollo
4Bayer Inc., Mississauga, ON, Canada
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J. Stuart Elborn
5National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK
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Elisabeth Operschall
6Bayer AG, Berlin, Germany
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Eva Polverino
7Hospital Universitari Vall d'Hebron, Institut de Recerca Vall d'Hebron, Barcelona, Spain
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Katrin Roth
6Bayer AG, Berlin, Germany
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Kevin L. Winthrop
8Oregon Health and Science University, Portland, OR, USA
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Robert Wilson
9Royal Brompton Hospital and Imperial College London, London, UK
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Abstract

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 α 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.

Abstract

RESPIRE 2 supports ciprofloxacin DPI clinical benefits in bronchiectasis, but did not reach statistical significance http://ow.ly/es9E30gNhos

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • This study is registered at ClinicalTrials.gov with identifier NCT02106832.

  • Support statement: This study was supported by Bayer AG. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com

  • Received October 6, 2017.
  • Accepted November 20, 2017.
  • Copyright ©ERS 2018
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RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis
Timothy Aksamit, Anthony De Soyza, Tiemo-Joerg Bandel, Margarita Criollo, J. Stuart Elborn, Elisabeth Operschall, Eva Polverino, Katrin Roth, Kevin L. Winthrop, Robert Wilson
European Respiratory Journal Jan 2018, 51 (1) 1702053; DOI: 10.1183/13993003.02053-2017

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RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis
Timothy Aksamit, Anthony De Soyza, Tiemo-Joerg Bandel, Margarita Criollo, J. Stuart Elborn, Elisabeth Operschall, Eva Polverino, Katrin Roth, Kevin L. Winthrop, Robert Wilson
European Respiratory Journal Jan 2018, 51 (1) 1702053; DOI: 10.1183/13993003.02053-2017
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