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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 416
- Primary Endpoint
- Time to First Exacerbation Event Within 48 Weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
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).
Intervention: Ciprofloxacin DPI (BAYQ3939) (Drug)
Ciprofloxacin DPI 14 Days on/off (Cipro 14)
Participants 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).
Intervention: Ciprofloxacin DPI (BAYQ3939) (Drug)
Placebo 28 Days on/off (Placebo 28)
Participants 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).
Intervention: Placebo (Drug)
Placebo 14 Days on/off (Placebo 14)
Participants 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).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to First Exacerbation Event Within 48 Weeks
Time Frame: Up to Week 48
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Secondary Outcomes
- Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks(Up to Week 48)
- Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks(Up to Week 48)
- Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)(End of treatment (Week 44/46))
- Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))
- Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)(End of treatment (Week 44/46))
- Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))
- Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)(Baseline and end of treatment (Week 44/46))