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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study

Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal 2013 41: 1107-1115; DOI: 10.1183/09031936.00071312
Robert Wilson
*Host Defence Unit, Royal Brompton Hospital, London
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  • For correspondence: r.wilson@rbht.nhs.uk
Tobias Welte
#Hannover Medical School, Hannover
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Eva Polverino
¶Hospital Clinic de Barcelona IDIBAPS, CIBERES, Barcelona, Spain
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Anthony De Soyza
+Newcastle University and Freeman Hospital, Newcastle upon Tyne, UK
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Hugh Greville
§Royal Adelaide Hospital, Adelaide, Australia
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Anne O'Donnell
fGeorgetown University Hospital, Washington, DC,
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Jeff Alder
**Bayer HealthCare Pharmaceuticals Inc., Montville, NJ, USA
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Peter Reimnitz
##Bayer Pharma AG, Wuppertal
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Barbara Hampel
¶¶Bayer Pharma AG, Berlin, Germany
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Abstract

This phase II, randomised, double-blind, multicentre study (NCT00930982) investigated the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis.

Adults who were culture positive for pre-defined potential respiratory pathogens (including Pseudomonas aeruginosa and Haemophilus influenzae) were randomised to ciprofloxacin DPI 32.5 mg or placebo administered twice daily for 28 days (with 56 days of follow-up). Bacterial density in sputum (primary end-point), pulmonary function tests, health-related quality of life and safety were monitored throughout the study.

60 subjects received ciprofloxacin DPI 32.5 mg and 64 received placebo. Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in total sputum bacterial load at the end of treatment (-3.62 log10 CFU·g−1 (range -9.78–5.02 log10 CFU·g−1)) compared with placebo (-0.27 log10 CFU·g−1 (range -7.96–5.25 log10 CFU·g−1)); the counts increased thereafter. In the ciprofloxacin DPI group, 14 (35%) out of 40 subjects reported pathogen eradication at end of treatment versus four (8%) out of 49 in the placebo group (p=0.001). No abnormal safety results were reported and rates of bronchospasm were low.

Ciprofloxacin DPI 32.5 mg twice daily for 28 days was well tolerated and achieved significant reductions in total bacterial load compared with placebo in subjects with non-cystic fibrosis bronchiectasis.

  • Antibiotic
  • bacteria
  • chronic lung infection
  • exacerbation
  • inflammation
  • Pseudomonas aeruginosa

Footnotes

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

  • Support Statement

    The study was sponsored by Bayer Pharma AG, Germany. R. Wilson and A. De Soyza wish to acknowledge the support of the National Institute for Health Research (NIHR) infrastructure in the form of NIHR Biomedical Research Unit funding (Royal Brompton Hospital, London, UK) and the Comprehensive Local Research Networks funding (other UK centres).

  • Clinical Trial

    This study is registered at www.clinicaltrials.gov with identifier number NCT00930982.

  • Statement of Interest

    Conflict of interest information can be found alongside the online version of this article at www.erj.ersjournals.com

  • This article was modified in April 2016 to correct errors in the licence information.

  • Received May 4, 2012.
  • Accepted September 15, 2012.
  • ©ERS 2013

ERJ Open articles are open access and distributed under the terms of the (Creative Commons Attribution Non-Commercial Licence 3.0)

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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal May 2013, 41 (5) 1107-1115; DOI: 10.1183/09031936.00071312

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Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh Greville, Anne O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal May 2013, 41 (5) 1107-1115; DOI: 10.1183/09031936.00071312
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