Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX1)
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AZLI
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Pulmonary Associates
- Arizona Pulmonary Specialists, LTD
- St. Joseph's Hospital and Medical Center Heart and Lung Institute
- Arizona Pulmonary Specialists
- David Geffen School of Medicine at UCLA
- UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
- Landon Pediatric Foundation
- National Jewish Health
- University of Connecticut Health Center
- Bay Area Chest Physicians
- University of Florida
- Pulmonary Disease Specialists (PDS) Research
- University of Miami - Miller School of Medicine
- Central Florida Pulmonary Group
- Cleveland Clinic Florida
- Atlanta Pulmonary Group
- Pulmonary and Critical Care Associates of Baltimore
- Mayo Clinic
- Cardio Pulmonary Research at St. Luke's Hospital
- Albany Medical Center
- Jamaica Hospital Medical Center
- Winthrop University Hospital - Clinical Trials Center
- St. Luke's Roosevelt Hospital
- University of Cincinnati / UC Health
- Oregon Health and Science University
- Drexel University College of Medicine
- University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
- Asthma Allergy & Pulmonary Associates
- Medical University of South Carolina
- Metroplex Pulmonary and Sleep Center
- Alamo Clinical Research Associates
- University of Texas Health Science Center at Tyler
- University of Virginia Pulmonary and Critical Care
- Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
- Swedish Medical Center/Minor James Clinic
- Multicare Pulmonary Specialist
- Concord Hospital
- St. Vincent's Hospital
- Woolcock Institute of Medical Research
- St. George Hospital
- Royal Perth Hospital
- Westmead Hospital
- Mater Adult Hospital
- The Prince Charles Hospital
- Royla Adelaide Hospital
- Repatriation General Hospital
- Respiratory Clinical Trials
- Monash Medical Centre
- Peninsula Health
- Alfred Hospital
- Sir Charles Gairdner Hospital
- University of Calgary
- University of Alberta
- Kelowna Respiratory and Allergy Clinic
- The Lung Centre at Vancouver General Hospital
- St. Paul's Hospital Pacific Lung Research
- Kingston General Hospital / Queen's University
- St. Michael's Hospital
- Dr. Anil Dhar Private Practice
- Centre Hospitalier de L'Université de Montréal Hotel Dieu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AZLI-AZLI
Placebo-AZLI
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in QOL-B Respiratory Symptoms Score at 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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01313624
Brief Title
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Acronym
AIR-BX1
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZLI-AZLI
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo-AZLI
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AZLI
Intervention Description
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match AZLI administered via nebulizer three times daily
Primary Outcome Measure Information:
Title
Change in QOL-B Respiratory Symptoms Score at Day 28
Description
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.
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Change in QOL-B Respiratory Symptoms Score at Day 84
Description
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 Frame
Baseline to Day 84
Title
Time to Protocol-Defined Exacerbation (PDE)
Description
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
Time Frame
Baseline to Day 112
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Barker, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arizona Pulmonary Specialists, LTD
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center Heart and Lung Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arizona Pulmonary Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Landon Pediatric Foundation
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Bay Area Chest Physicians
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pulmonary Disease Specialists (PDS) Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Central Florida Pulmonary Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Atlanta Pulmonary Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pulmonary and Critical Care Associates of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cardio Pulmonary Research at St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Winthrop University Hospital - Clinical Trials Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
St. Luke's Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
University of Cincinnati / UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Asthma Allergy & Pulmonary Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Metroplex Pulmonary and Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Alamo Clinical Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
University of Virginia Pulmonary and Critical Care
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Swedish Medical Center/Minor James Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Multicare Pulmonary Specialist
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Woolcock Institute of Medical Research
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
New South Wales
ZIP/Postal Code
6000
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royla Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Repatriation General Hospital
City
Daws Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Respiratory Clinical Trials
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peninsula Health
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Alfred Hospital
City
Westmead
State/Province
Victoria
ZIP/Postal Code
3194
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Kelowna Respiratory and Allergy Clinic
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 1V3
Country
Canada
Facility Name
The Lung Centre at Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital Pacific Lung Research
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Kingston General Hospital / Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Dr. Anil Dhar Private Practice
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Centre Hospitalier de L'Université de Montréal Hotel Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25154045
Citation
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.
Results Reference
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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
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