Overview

This trial has been completed.

Condition non cystic fibrosis bronchiectasis
Treatments pulmaquin, placebo
Phase phase 3
Sponsor Aradigm Corporation
Collaborator Grifols Therapeutics Inc.
Start date April 2014
End date August 2016
Trial size 304 participants
Trial identifier NCT02104245, ARD-3150-1202

Summary

This study (ARD-3150-1201, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Pulmaquin: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin
pulmaquin
(Placebo Comparator)
Placebo: Liquid formulation of empty liposomes
placebo

Primary Outcomes

Measure
Time to first pulmonary exacerbation (from baseline)
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
Description This is a multinational, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin compared to placebo in the management of chronic lung infections with P. aeruginosa in subjects with non-CF bronchiectasis with a history of pulmonary exacerbations. This study will consist of a Screening Phase, a Double-Blind Phase (6 cycles each consisting of 28-days once daily Pulmaquin or Placebo, and 28 days off treatment) followed by Open-Label Extension (28 days on Pulmaquin).
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Aradigm Corporation.