Brief Title
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Official Title
Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Brief 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.
Detailed Description
Number of participants with Adverse events will be covered in Adverse Events section.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Secondary Outcome
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Condition
Bronchiectasis
Intervention
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Study Arms / Comparison Groups
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Description: Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
521
Start Date
April 30, 2014
Completion Date
October 19, 2016
Primary Completion Date
September 13, 2016
Eligibility Criteria
Inclusion Criteria: - Patients with a proven and documented diagnosis of non 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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT02106832
Organization ID
15626
Secondary IDs
2013-004659-19
Responsible Party
Sponsor
Study Sponsor
Bayer
Collaborators
Novartis
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
September 2017