NCT01515007CompletedPhase 3
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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aradigm Corporation
- Enrollment
- 278
- Primary Endpoint
- Time to first exacerbation
Study Overview
Brief Summary
This study (ARD-3150-1201, ORBIT-3) 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.
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
- •Verified bronchiectasis diagnosis
- •Pseudomonas aeruginosa lung infection
Exclusion Criteria
- •Cystic Fibrosis
Arms & Interventions
Ciprofloxacin dispersion for inhalation
Experimental
Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
Intervention: Ciprofloxacin dispersion for inhalation (Drug)
Placebo
Placebo Comparator
Liquid formulation of empty liposomes
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to first exacerbation
Time Frame: One Year
Secondary Outcomes
- Number of exacerbations(One Year)
Investigators
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