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

Phase 3

Completed

• Conditions: Non Cystic Fibrosis Bronchiectasis
• Interventions: Drug: Placebo; Drug: Ciprofloxacin dispersion for inhalation

• Registration Number: NCT02104245
• Lead Sponsor: Aradigm Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-28
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Study Start: 2014-05-28
• Primary Completion: 2016-08-11
• Study Completion: 2016-10
• Disposition First Submitted: 2018-01-08
• Disposition First Submitted QC: 2018-01-08
• Disposition First Posted: 2018-01-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Liquid formulation of empty liposomes
Ciprofloxacin dispersion for inhalation	Ciprofloxacin dispersion for inhalation	Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin

Primary Outcome Measures

Name	Time	Method
Time to first pulmonary exacerbation (from baseline)	48 weeks