Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/21/2018 |
| Start Date: | April 2014 |
| End Date: | October 2016 |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled
Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects
who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history
of pulmonary exacerbations and chronic P. aeruginosa infections.
Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects
who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history
of pulmonary exacerbations and chronic P. aeruginosa infections.
Inclusion Criteria:
- Confirmed diagnosis of non-CF bronchiectasis
- History of P. aeruginosa respiratory infections
- At least two pulmonary exacerbations treated with antibiotics in the previous year
Exclusion Criteria:
- Have a clinical diagnosis of CF
- Are pregnant
We found this trial at
26
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