Clinical Trials List
Protocol NumberARD3150-1202
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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension(ORBIT-4)
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Trial Applicant
CHILTERN RESEARCH INTERNATIONAL (SINGAPORE) PTE. LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- jong rung Tsai Division of Thoracic Medicine
- Chau-Chyun Sheu Division of Thoracic Medicine
- Jen-Yu Hung Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Chronic Lung Infections With Pseudomonas Aeruginosa
Objectives
This study (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.
Test Drug
Pulmaquin
Active Ingredient
Dosage Form
Nebulizer
Dosage
150mg / 60mg
Endpoints
Primary Outcome Measures :
Time to first pulmonary exacerbation (from baseline)
Time to first pulmonary exacerbation (from baseline)
Inclution Criteria
A
Exclusion Criteria
A
The Estimated Number of Participants
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Taiwan
30 participants
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Global
255 participants
