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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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19 October 2017 |
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Main ID: |
NCT01313624 |
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Date of registration:
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10/03/2011 |
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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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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
AIR-BX1 |
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Scientific title:
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A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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266 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01313624 |
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Study type:
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Interventional |
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Study design:
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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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United States
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Contacts
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Name:
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Alan Barker, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male/Female 18 years or older with non-CF bronchiectasis
- Chronic sputum production on most days
- Positive sputum culture for gram-negative organisms
- Must have met lung function requirements
Exclusion Criteria:
- History of CF
- Hospitalized within 14 days prior to joining the study
- Previous exposure to AZLI
- Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
- Must have met liver and kidney function requirements
- Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with
activity and at night was allowed)
- Treatment for nontuberculous mycobacteria infection or active mycobacterium
tuberculosis infection within 1 year of enrollment
- Other serious medical conditions.
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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Bronchiectasis
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Intervention(s)
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Drug: Placebo
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Drug: AZLI
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Primary Outcome(s)
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Change in QOL-B Respiratory Symptoms Score at Day 28
[Time Frame: Baseline to Day 28]
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Secondary Outcome(s)
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Time to Protocol-Defined Exacerbation (PDE)
[Time Frame: Baseline to Day 112]
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Change in QOL-B Respiratory Symptoms Score at Day 84
[Time Frame: Baseline to Day 84]
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Secondary ID(s)
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GS-US-219-0101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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