Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

• Status: Completed
• Trial end date: 2016-03-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Novartis
• Treatments: Ciprofloxacin

Criteria

Inclusion Criteria:

• Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis

• Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Exclusion Criteria:

• Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted

• Active allergic bronchopulmonary aspergillosis

• Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis

• Primary diagnosis of Chronic obstructive pulmonary disease (COPD)