Phase 2
N=124
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis
Bottom Line
View on ClinicalTrials.gov: NCT00930982 ↗Enrolled (actual)
124
Serious AEs
8.1%
Results posted
Jan 2012
Primary outcome: Primary: Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). — -2.94; -0.32 log10 of CFU per gram sputum — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ciprofloxacin (Cipro, BAYQ3939) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). |
-2.94; -0.32 | < 0.001 sig |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
-0.67; -0.14; -0.53; -0.22; 1.19; -0.26 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
-0.33; 0.04; -0.76; -1.05; 0.92; -1.09 | — |
| SECONDARY Time to Exacerbation With Antibiotic Intervention |
NA; NA | — |
| SECONDARY Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score |
43.8; 44.7; 41.5; 44.8; 40.6; 44.1 | — |
| SECONDARY Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) |
4.88; 4.96; 4.99; 4.93; 4.94; 4.91 | — |
| SECONDARY Change From Baseline in High Sensitive C-reactive Protein (hsCRP) |
-0.43; -0.19; 0; 0; -0.16; 0.12 | — |
| SECONDARY Change From Baseline in Absolute Neutrophil Count (ANC) |
-0.35; -0.03; -0.36; 0.59; -0.28; 0.24 | — |
| SECONDARY 24-hour Sputum Volume |
24.9; 30.2; 18.9; 30.0; 20.5; 27.3 | — |
| SECONDARY 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum) |
91.7; 88.9; 73.2; 94.9; 75.5; 82.7 | — |
| SECONDARY Microbiological Response of Cipro Inhale Per Participant |
100.0; 100.0; 52.4; 88.2; 65.0; 91.8 | — |
| SECONDARY Microbiological Response of Cipro Inhale Per Pathogen |
8; 17; 4; 7; 5; 10 | — |
| SECONDARY Emergence of New Potential Respiratory Pathogens |
1; 0; 1; 2; 2; 2 | — |
| SECONDARY Emergence of Resistance Among Baseline Pathogens |
7; 1; 1; 0; 5; 1 | — |
Summary
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
Eligibility Criteria
Inclusion Criteria
- Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or post pneumonic bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the past 30 days
Exclusion Criteria
- Forced Expiratory Volume 1 80%
- Allergic bronchopulmonary aspergillosis
- Immunodeficiency disease requiring immunoglobulin replacement
- Inflammatory bowel disease
Data sourced from ClinicalTrials.gov (NCT00930982). 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.