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

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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 (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.
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3181 Southwest Sam Jackson Park Road
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2950 Cleveland Clinic Blvd.
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