Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/4/2017 |
| Start Date: | April 30, 2014 |
| End Date: | October 19, 2016 |
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.
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.
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.
Number of participants with Adverse events will be covered in Adverse Events section.
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)
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