NCT00930982

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

Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during \>=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting \>=3 days.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Ciprofloxacin (Cipro, BAYQ3939)	Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
DRUG	Placebo	Inhalation of matching placebo twice a day

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-07-02
• Last updated: 2014-12-12
• Results posted: 2012-01-30

Locations

47 sites across 6 countries: United States, Australia, Germany, Spain, Sweden, United Kingdom