Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
- Registration Number
- NCT01314716
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZLI-AZLI AZLI Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up. Placebo-AZLI AZLI Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up. Placebo-AZLI Placebo Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
- Primary Outcome Measures
Name Time Method Change in QOL-B Respiratory Symptoms Score at Day 28 Baseline to Day 28 The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
- Secondary Outcome Measures
Name Time Method Change in QOL-B Respiratory Symptoms Score at Day 84 Baseline to Day 84 The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time to Protocol-Defined Exacerbation (PDE) Baseline to Day 112 Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.
* Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
* Minor Criteria: fever (\> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased \> 10% from baseline; new or increased hemoptysis
Trial Locations
- Locations (85)
Florence Research Associates
🇺🇸Florence, Alabama, United States
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, District of Columbia, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
Scroll for more (75 remaining)Florence Research Associates🇺🇸Florence, Alabama, United States