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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 April 2021 |
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Main ID: |
NCT02104245 |
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Date of registration:
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28/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
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Scientific title:
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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 |
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Date of first enrolment:
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May 28, 2014 |
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Target sample size:
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304 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02104245 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Former Serbia and Montenegro
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France
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Georgia
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Germany
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Hungary
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Israel
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Italy
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Korea, Republic of
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New Zealand
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Peru
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Poland
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Romania
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Spain
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non Cystic Fibrosis Bronchiectasis
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Intervention(s)
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Drug: Placebo
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Drug: Ciprofloxacin dispersion for inhalation
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Primary Outcome(s)
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Time to first pulmonary exacerbation (from baseline)
[Time Frame: 48 weeks]
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Secondary ID(s)
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ARD-3150-1202
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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