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

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 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

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