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-BX1 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

NCT01313624

Run by

Gilead Sciences

People needed

266

Starts

2011-04-01

Expected to finish

2013-06-01

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

• Arizona Pulmonary Specialists, LTD — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center Heart and Lung Institute — Phoenix, Arizona, United States
• Arizona Pulmonary Specialists — Scottsdale, Arizona, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine — Sacramento, California, United States
• Landon Pediatric Foundation — Ventura, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Bay Area Chest Physicians — Clearwater, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Pulmonary Disease Specialists (PDS) Research — Kissimmee, Florida, United States
• University of Miami - Miller School of Medicine — Miami, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Atlanta Pulmonary Group — Atlanta, Georgia, United States
• Pulmonary and Critical Care Associates of Baltimore — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cardio Pulmonary Research at St. Luke's Hospital — Chesterfield, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• Winthrop University Hospital - Clinical Trials Center — Mineola, New York, United States
• St. Luke's Roosevelt Hospital — New York, New York, United States
• University of Cincinnati / UC Health — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Pulmonary Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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