NCT00889967

Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"

An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Aradigm Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.

Conditions

• Non-Cystic Fibrosis Bronchiectasis

Interventions

Type	Name	Description
DRUG	Ciprofloxacin for Inhalation	100 mg once daily by inhalation for 28 days
DRUG	Ciprofloxacin for Inhalation	150 mg once daily by inhalation for 28 days
DRUG	Placebo	Placebo once daily by inhalation for 28 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2009-04-29
• Last updated: 2017-01-25

Locations

37 sites across 4 countries: United States, Canada, Germany, United Kingdom