A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX2
| Status: | Completed |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | April 2011 |
| End Date: | June 2013 |
A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
The AIR-BX-2 study is for people who have been diagnosed with non-CF bronchiectasis and have
gram-negative airway infection. This is a randomized study, the participants will be
selected by chance (like flipping a coin) to receive one of two treatments (AZLI or
Placebo). This is a double-blind study which means participants and their study doctors will
not know what treatment they are assigned to receive. Participants will receive two 28 day
courses of either AZLI or placebo taken 3 times a day. Each course has a 28 day off-drug
period. Following the blinded courses, all participants will receive AZLI for the third 28
day course.
Based on observed safety and effectiveness of AZLI in the adult CF population, and due to
the similarities in the lung disease for patients with CF and non-CF bronchiectasis, AZLI
represents a potential treatment for people with non-CF bronchiectasis and infection of the
airways.
There will be 10 scheduled study visits. Planned visits include screening prior to
randomization, evaluations at 14-day intervals during the first placebo-controlled course,
and every 28 days subsequently.
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 meet lung function requirements
Exclusion Criteria:
- History of CF
- Hospitalized within 14 days prior to joining the study
- Previous exposure to AZLI for inhalation
- Pregnant, breastfeeding or unwilling to follow contraceptive measures for the study
- Must meet liver and kidney function requirements
- Continuous oxygen use of greater than 2 Liters per minute (supplemental oxygen with
activity and at night is allowed)
- Current treatment for nontuberculous mycobacteria infection or active mycobacterium
tuberculosis infection within 1 year of enrollment
- Other serious medical conditions
We found this trial at
33
sites
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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University of Utah Research is a major component in the life of the U benefiting...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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