Phase 3
N=521
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT02106832 ↗Enrolled (actual)
521
Serious AEs
22.0%
Results posted
Sep 2017
Primary outcome: Primary: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo — NA; NA Days — p=0.0511
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ciprofloxacin (BAYQ3939) dry powder for inhalation (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo |
NA; NA | 0.0511 |
| PRIMARY Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo |
NA; NA | 0.3965 |
| SECONDARY Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks |
115; 108; 101; 46; 40; 41 | — |
| SECONDARY Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks |
102; 96; 90; 51; 46; 45 | — |
| SECONDARY Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) |
35.1; 35.8; 40.2; 31.6; 35.8; 31.6 | — |
| SECONDARY Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46) |
-8.92; -9.02; -2.91; -11.50 | — |
| SECONDARY Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) |
62.6; 67.6; 61.5; 4.1; 4.0; 10.3 | — |
| SECONDARY 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) |
11.57; 10.90; 7.08; 10.70 | — |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46) |
0.038; -0.037; -0.038; 0.037 | — |
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.
Eligibility Criteria
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) 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)
Data sourced from ClinicalTrials.gov (NCT02106832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.