Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aradigm Corporation
• Collaborators: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: Ciprofloxacin

Criteria

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