Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
AIR-BX1
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
1 other identifier
interventional
266
3 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2011
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
April 16, 2014
CompletedApril 16, 2014
March 1, 2014
1.9 years
March 10, 2011
March 7, 2014
March 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in QOL-B Respiratory Symptoms Score at 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.
Baseline to Day 28
Secondary Outcomes (2)
Change in QOL-B Respiratory Symptoms Score at Day 84
Baseline to Day 84
Time to Protocol-Defined Exacerbation (PDE)
Baseline to Day 112
Study Arms (2)
AZLI-AZLI
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (60)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85012, United States
St. Joseph's Hospital and Medical Center Heart and Lung Institute
Phoenix, Arizona, 85013, United States
Arizona Pulmonary Specialists
Scottsdale, Arizona, 85258, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
Sacramento, California, 95817, United States
Landon Pediatric Foundation
Ventura, California, 93003, United States
National Jewish Health
Denver, Colorado, 80202, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Bay Area Chest Physicians
Clearwater, Florida, 33756, United States
University of Florida
Gainesville, Florida, 32610, United States
Pulmonary Disease Specialists (PDS) Research
Kissimmee, Florida, 34741, United States
University of Miami - Miller School of Medicine
Miami, Florida, 33136, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Atlanta Pulmonary Group
Atlanta, Georgia, 30342, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21204, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cardio Pulmonary Research at St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
Albany Medical Center
Albany, New York, 12208, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Winthrop University Hospital - Clinical Trials Center
Mineola, New York, 11501, United States
St. Luke's Roosevelt Hospital
New York, New York, 10019, United States
University of Cincinnati / UC Health
Cincinnati, Ohio, 45267, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
Philadelphia, Pennsylvania, 19104, United States
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069, United States
Alamo Clinical Research Associates
San Antonio, Texas, 78212, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
University of Virginia Pulmonary and Critical Care
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
Falls Church, Virginia, 22042, United States
Swedish Medical Center/Minor James Clinic
Seattle, Washington, 98104, United States
Multicare Pulmonary Specialist
Tacoma, Washington, 98405, United States
Concord Hospital
Concord, New South Wales, 2139, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010, Australia
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037, Australia
St. George Hospital
Kogarah, New South Wales, 2217, Australia
Royal Perth Hospital
Perth, New South Wales, 6000, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Mater Adult Hospital
Brisbane, Queensland, 4101, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royla Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Repatriation General Hospital
Daws Park, South Australia, 5041, Australia
Respiratory Clinical Trials
Toorak Gardens, South Australia, 5065, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Peninsula Health
Frankston, Victoria, 3199, Australia
Alfred Hospital
Westmead, Victoria, 3194, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, V1W 1V3, Canada
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital Pacific Lung Research
Vancouver, British Columbia, V6Z 1Y6, Canada
Kingston General Hospital / Queen's University
Kingston, Ontario, K7L 2V6, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Dr. Anil Dhar Private Practice
Windsor, Ontario, N8X 5A6, Canada
Centre Hospitalier de L'Université de Montréal Hotel Dieu
Montreal, Quebec, H2W 1T8, Canada
Related Publications (1)
Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.
PMID: 25154045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Barker, MD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2011
First Posted
March 14, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
April 16, 2014
Results First Posted
April 16, 2014
Record last verified: 2014-03