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

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.

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Key information

Conditions

Non Cystic Fibrosis Bronchiectasis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pseudomonas Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Greenslopes, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofloxacin dispersion for inhalation

Drug

Placebo

Drug

Primary outcomes

Time to first pulmonary exacerbation (from baseline)

Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Aradigm Corporation

Industry

Collaborators

Grifols Therapeutics LLC

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Apr 4, 2014
Registry last updated: Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed