Phase 3
Completed N=416
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Source: ClinicalTrials.gov NCT01764841 ↗Enrolled (actual)
416
Serious AEs
20.3%
Results posted
May 2017
Primary outcomePrimary: Time to First Exacerbation Event Within 48 Weeks — 336; NA; 186 Days — p=0.0650
◆ Published Evidence
Highly cited
189citations · ~24 / year
RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.
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.
Linked Publications (2)
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RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.
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The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Exacerbation Event Within 48 Weeks |
336; NA; 186 | 0.0650 |
| SECONDARY Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks |
66; 72; 44; 44; 38; 58 | 0.2944 |
| SECONDARY Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks |
58; 68; 46; 47; 42; 43 | — |
| SECONDARY Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) |
39.0; 26.3; 33.3; 24.1; 28.5; 16.7 | — |
| 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) |
-8.17; -7.20; -4.23; 2.78 | — |
| SECONDARY Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) |
60.3; 49.6; 42.8; 3.5; 5.1; 8.0 | — |
| 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) |
7.70; 6.72; 8.22; 4.45 | — |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46) |
-0.012; -0.026; 0.024; 0.022 | — |
Eligibility Criteria
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) 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 (NCT01764841) and the linked publication. 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. Informational only — not medical advice.