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OpenTrials
Completed

NCT Number: NCT01515007

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

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.

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Key information

Conditions

Non Cystic Fibrosis Bronchiectasis Bronchial Diseases Bronchiectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Concord, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Verified bronchiectasis diagnosis
  • Pseudomonas aeruginosa lung infection

Exclusion criteria

  • Cystic Fibrosis

Treatment and study plan

Ciprofloxacin dispersion for inhalation

Drug

Other names: Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin

Placebo

Drug

Other names: Liquid formulation of empty liposomes

Primary outcomes

  1. Time to first exacerbation

    Time frame: One Year

Secondary outcomes

  1. Number of exacerbations

    Time frame: One Year

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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2012
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.

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