NCT01515007

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Aradigm Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	Ciprofloxacin dispersion for inhalation
DRUG	Placebo

Timeline

• Start date: 2014-03-31
• Primary completion: 2016-08-17
• Completion: 2016-10-01
• First posted: 2012-01-23
• Last updated: 2021-03-26

Locations

109 sites across 16 countries: United States, Australia, Canada, Germany, Hungary, Ireland, Israel, Italy, Latvia, Poland, Romania, South Africa, South Korea, Spain, Taiwan, United Kingdom