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Efficacy and safety of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis

Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh W. Greville, Anne E. O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal 2011 38: 1929; DOI:
Robert Wilson
1Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom
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Tobias Welte
2Klinik fuer Pneumologie, Medizinische Hochschule Hannover, Hannover, Germany
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Eva Polverino
3Servicio de Pneumol., Hospital Clinic i Provincial, Barcelona, Spain
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Anthony De Soyza
4Sir William Leech Centre for Lung Research, Freeman Hospital, Newcastle upon Tyne, United Kingdom
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Hugh W. Greville
5Chest Clinic, Royal Adelaide Hospital, Adelaide, Australia
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Anne E. O'Donnell
6Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Hospital, Washington, DC, United States
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Jeff Alder
7Global Clinical Development, Bayer HealthCare Pharmaceuticals Inc, Montville, NJ, United States
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Peter Reimnitz
8Global Clinical Development, Bayer Schering Pharma AG, Wuppertal, Germany
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Barbara Hampel
9Global Clinical Development Antiinfectives, Bayer Schering Pharma AG, Berlin, Germany
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Abstract

Introduction: Ciprofloxacin dry powder for inhalation (DPI) uses PulmoSphere™ technology to target the lungs of patients chronically colonized with bacterial pathogens.

Objective: This phase II study assessed the efficacy and safety of ciprofloxacin DPI treatment for 28 days in non-cystic fibrosis bronchiectasis (non-CF BE) patients.

Methods: Adult patients with pulmonary stable non-CF BE received twice-daily 32.5 mg ciprofloxacin (50 mg ciprofloxacin DPI) or matching placebo for 28 days, with a 56-day follow-up. The primary endpoint was reduction in total bacterial load in sputum at end of treatment (EOT) compared with placebo.

Results: The mean baseline characteristics in the intent-to-treat population (N=124) were: age 63, weight 70 kg, FEV1 56% of predicted. At EOT, ciprofloxacin DPI reduced mean bacterial load by 3.6 logs, vs 0.3 logs with placebo (p<0.001), and median CRP level was 2.45 mg/l lower compared with placebo (not significant). Mean difference in the St George's Respiratory Questionnaire at EOT was 3.6 points between treatment arms (p=0.059). Fewer patients treated with ciprofloxacin DPI than with placebo experienced an exacerbation requiring antibiotic treatment (23% vs 28%, not significant). The adverse event rate was similar in both treatment arms. Very few bronchospasms occurred (n=6, 2 after EOT). They were equally distributed between both groups.

Conclusions: Ciprofloxacin DPI significantly reduced bacterial load in patients with non-CF BE (p<0.001) and was well tolerated. Several secondary endpoints showed a trend in favour of ciprofloxacin DPI. Ciprofloxacin DPI is a promising candidate for investigating benefits of long-term therapy in non-CF BE patients.

  • © 2011 ERS
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Efficacy and safety of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh W. Greville, Anne E. O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal Sep 2011, 38 (Suppl 55) 1929;

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Efficacy and safety of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis
Robert Wilson, Tobias Welte, Eva Polverino, Anthony De Soyza, Hugh W. Greville, Anne E. O'Donnell, Jeff Alder, Peter Reimnitz, Barbara Hampel
European Respiratory Journal Sep 2011, 38 (Suppl 55) 1929;
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More in this TOC Section

  • Antimicrobial efficacy of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis
  • Dual release ciprofloxacin for inhalation (DRCFI) reduces sputum pseudomonas aeruginosa (Pa) density and delays time to infective pulmonary exacerbation in non-cystic fibrosis (CF) bronchiectasis (BE)
Show more 241. Advances in antibiotic therapy of non-cystic fibrosis bronchiectasis

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