Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
- Registration Number
- NCT01313624
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- 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 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. 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 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 (60)
Bay Area Chest Physicians
🇺🇸Clearwater, Florida, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
Cardio Pulmonary Research at St. Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Royla Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Arizona Pulmonary Specialists, LTD
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center Heart and Lung Institute
🇺🇸Phoenix, Arizona, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Miami - Miller School of Medicine
🇺🇸Miami, Florida, United States
Alamo Clinical Research Associates
🇺🇸San Antonio, Texas, United States
Swedish Medical Center/Minor James Clinic
🇺🇸Seattle, Washington, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Landon Pediatric Foundation
🇺🇸Ventura, California, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Pulmonary Disease Specialists (PDS) Research
🇺🇸Kissimmee, Florida, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Winthrop University Hospital - Clinical Trials Center
🇺🇸Mineola, New York, United States
St. Luke's Roosevelt Hospital
🇺🇸New York, New York, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Atlanta Pulmonary Group
🇺🇸Atlanta, Georgia, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Woolcock Institute of Medical Research
🇦🇺Glebe, New South Wales, Australia
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
St. George Hospital
🇦🇺Kogarah, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Repatriation General Hospital
🇦🇺Daws Park, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
The Lung Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Kelowna Respiratory and Allergy Clinic
🇨🇦Kelowna, British Columbia, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
St. Paul's Hospital Pacific Lung Research
🇨🇦Vancouver, British Columbia, Canada
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Kingston General Hospital / Queen's University
🇨🇦Kingston, Ontario, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Virginia Pulmonary and Critical Care
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
🇺🇸Falls Church, Virginia, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Metroplex Pulmonary and Sleep Center
🇺🇸McKinney, Texas, United States
Arizona Pulmonary Specialists
🇺🇸Scottsdale, Arizona, United States
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
🇺🇸Sacramento, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Cincinnati / UC Health
🇺🇸Cincinnati, Ohio, United States
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Mater Adult Hospital
🇦🇺Brisbane, Queensland, Australia
Respiratory Clinical Trials
🇦🇺Toorak Gardens, South Australia, Australia
Centre Hospitalier de L'Université de Montréal Hotel Dieu
🇨🇦Montreal, Quebec, Canada
Dr. Anil Dhar Private Practice
🇨🇦Windsor, Ontario, Canada
Multicare Pulmonary Specialist
🇺🇸Tacoma, Washington, United States
Asthma Allergy & Pulmonary Associates
🇺🇸Philadelphia, Pennsylvania, United States
Concord Hospital
🇦🇺Concord, New South Wales, Australia
Royal Perth Hospital
🇦🇺Perth, New South Wales, Australia
Peninsula Health
🇦🇺Frankston, Victoria, Australia
Alfred Hospital
🇦🇺Westmead, Victoria, Australia