Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

Key facts

Study ID

NCT01314716

Run by

Gilead Sciences

People needed

274

Starts

2011-04-01

Expected to finish

2013-07-01

Last updated by the study team

2014-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Trials Connection — Flagstaff, Arizona, United States
• Phoenix Medical Group — Peoria, Arizona, United States
• Pulmonary Associates — Phoenix, Arizona, United States
• AZ Pulmonary Specialists, LTD — Scottsdale, Arizona, United States
• Pulmonary Consultants & Primary Care Physicians Medical Group, Inc. — Orange, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Sarasota Memorial Hospital - Clinical Research Center — Sarasota, Florida, United States
• Pasadena Center for Medical Research — St. Petersburg, Florida, United States
• Tampa General Hospital - New Lung Associates — Tampa, Florida, United States
• Florida Premier Research Institute — Winter Park, Florida, United States
• Southeastern Lung Care PC — Decatur, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Loess Hills Clinical Research — Council Bluffs, Iowa, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Pulmonary & Critical Care Associates of Baltimore — Rosedale, Maryland, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Pulmonary & Allergy Associates, P.A. — Summit, New Jersey, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• Columbia University, NY Presbyterian Hospital — New York, New York, United States
• Florence Research Associates — Florence, Alabama, United States

Full record on ClinicalTrials.gov

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