Trials / Completed
CompletedNCT02106832
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 521 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ciprofloxacin (BAYQ3939) dry powder for inhalation | Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment. |
| DRUG | Ciprofloxacin (BAYQ3939) dry powder for inhalation | Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment. |
| DRUG | Placebo | Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off |
| DRUG | Placebo | Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off |
Timeline
- Start date
- 2014-04-30
- Primary completion
- 2016-09-13
- Completion
- 2016-10-19
- First posted
- 2014-04-08
- Last updated
- 2017-10-02
- Results posted
- 2017-09-01
Locations
207 sites across 25 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, China, Czechia, Germany, Hong Kong, Latvia, Lithuania, Netherlands, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02106832. Inclusion in this directory is not an endorsement.