Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

Phase 2 Completed 124 enrolled Bayer Novartis · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

Timeline

Start: 2009-06
Primary completion: 2010-09
Completion: 2010-09

Outcome

Met primary endpoint

paper Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in total sputum bacterial load at the end of treatment PMID 23018904 ↗

paper 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. PMID 23018904 ↗

Publications

Results Wilson R, Welte T, Polverino E, De Soyza A, Greville H, O'Donnell A, Alder J, Reimnitz P, Hampel B. Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study. Eur Respir J. 2013 May;41(5):1107-15. doi: 10.1183/09031936.00071312. Epub 2012 Sep 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ciprofloxacin	Small molecule	32.5 mg	Inhaled