Brief Title
Ciprofloxacin Dry Powder for Inhalation 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. The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Time to First Exacerbation Event Within 48 Weeks
Secondary Outcome
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Condition
Bronchiectasis
Intervention
Ciprofloxacin DPI (BAYQ3939)
Study Arms / Comparison Groups
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Description: Participants 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
416
Start Date
May 2, 2013
Completion Date
March 9, 2016
Primary Completion Date
March 9, 2016
Eligibility 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)
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
NCT01764841
Organization ID
15625
Secondary IDs
2011-004208-39
Responsible Party
Sponsor
Study Sponsor
Bayer
Collaborators
Novartis
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
January 2018