Clinical Trials List
Protocol NumberARD3150-1201
2015-05-01 - 2017-12-31
Phase III
Terminated1
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)
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Trial Applicant
CHILTERN RESEARCH INTERNATIONAL (SINGAPORE) PTE. LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Jen-Yu Hung Division of Thoracic Medicine
- jong rung Tsai Division of Thoracic Medicine
- Chau-Chyun Sheu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Chronic Lung Infections With Pseudomonas Aeruginosa
Objectives
This study 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.
Test Drug
Pulmaquin®
Active Ingredient
Dosage Form
Nebulizer
Dosage
150mg / 60mg
Endpoints
Primary Outcome Measures :
Time to first exacerbation [ Time Frame: One Year ]
Secondary Outcome Measures :
Number of exacerbations [ Time Frame: One Year ]
Time to first exacerbation [ Time Frame: One Year ]
Secondary Outcome Measures :
Number of exacerbations [ Time Frame: One Year ]
Inclution Criteria
Inclusion Criteria:
Verified bronchiectasis diagnosis
Pseudomonas aeruginosa lung infection
Verified bronchiectasis diagnosis
Pseudomonas aeruginosa lung infection
Exclusion Criteria
Exclusion Criteria:
Cystic Fibrosis
Cystic Fibrosis
The Estimated Number of Participants
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Taiwan
30 participants
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Global
225 participants
