Conditions: Bronchiectasis
Keywords: Ciprofloxacin Dry Powder for Inhalation Exacerbation Bronchiectasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 521
Healthy volunteers: no

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.

Arms:
arm 1: 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). arm 2: Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). arm 3: Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered 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 cycles). arm 4: Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).

Interventions: intervention 1: Ciprofloxacin (BAYQ3939) dry powder for inhalation intervention 2: Ciprofloxacin (BAYQ3939) dry powder for inhalation intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment. intervention 2: Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment. intervention 3: Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off intervention 4: Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

Protocol document: