A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX1
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | April 2011 |
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 (AIR-BX1)
The AIR-BX-1 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 two 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 diseases for patients with CF and non-CF bronchiectasis, AZLI
represents a potential treatment option for people with non-CF bronchiectasis and infection
of the airways.
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
35
sites
400 Redland Ct.
Owings Mills, Maryland 21136
Owings Mills, Maryland 21136
410-494-7921
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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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Falls Church, Virginia 22042
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263 Farmington Ave
Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, Pennsylvania 19104
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Sacramento, California 95817
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