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Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX1)

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ClinicalTrials.gov Identifier: NCT01313624
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: AZLI Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: 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.
Drug: AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

Placebo Comparator: Placebo-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.
Drug: AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

Drug: Placebo
Placebo to match AZLI administered via nebulizer three times daily




Primary Outcome Measures :
  1. Change in QOL-B Respiratory Symptoms Score at Day 28 [ Time Frame: 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 :
  1. Change in QOL-B Respiratory Symptoms Score at Day 84 [ Time Frame: 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.

  2. Time to Protocol-Defined Exacerbation (PDE) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313624


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Locations
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United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States, 85012
St. Joseph's Hospital and Medical Center Heart and Lung Institute
Phoenix, Arizona, United States, 85013
Arizona Pulmonary Specialists
Scottsdale, Arizona, United States, 85258
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
Sacramento, California, United States, 95817
Landon Pediatric Foundation
Ventura, California, United States, 93003
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80202
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Bay Area Chest Physicians
Clearwater, Florida, United States, 33756
University of Florida
Gainesville, Florida, United States, 32610
Pulmonary Disease Specialists (PDS) Research
Kissimmee, Florida, United States, 34741
University of Miami - Miller School of Medicine
Miami, Florida, United States, 33136
Central Florida Pulmonary Group
Orlando, Florida, United States, 32803
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Atlanta Pulmonary Group
Atlanta, Georgia, United States, 30342
United States, Maryland
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States, 21204
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Cardio Pulmonary Research at St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
Winthrop University Hospital - Clinical Trials Center
Mineola, New York, United States, 11501
St. Luke's Roosevelt Hospital
New York, New York, United States, 10019
United States, Ohio
University of Cincinnati / UC Health
Cincinnati, Ohio, United States, 45267
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
Philadelphia, Pennsylvania, United States, 19104
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States, 75069
Alamo Clinical Research Associates
San Antonio, Texas, United States, 78212
University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
United States, Virginia
University of Virginia Pulmonary and Critical Care
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
Falls Church, Virginia, United States, 22042
United States, Washington
Swedish Medical Center/Minor James Clinic
Seattle, Washington, United States, 98104
Multicare Pulmonary Specialist
Tacoma, Washington, United States, 98405
Australia, New South Wales
Concord Hospital
Concord, New South Wales, Australia, 2139
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037
St. George Hospital
Kogarah, New South Wales, Australia, 2217
Royal Perth Hospital
Perth, New South Wales, Australia, 6000
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Mater Adult Hospital
Brisbane, Queensland, Australia, 4101
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royla Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Repatriation General Hospital
Daws Park, South Australia, Australia, 5041
Respiratory Clinical Trials
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Peninsula Health
Frankston, Victoria, Australia, 3199
Alfred Hospital
Westmead, Victoria, Australia, 3194
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, Canada, V1W 1V3
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
St. Paul's Hospital Pacific Lung Research
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Kingston General Hospital / Queen's University
Kingston, Ontario, Canada, K7L 2V6
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Dr. Anil Dhar Private Practice
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Centre Hospitalier de L'Université de Montréal Hotel Dieu
Montreal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Gilead Sciences
Investigators
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Principal Investigator: Alan Barker, MD Oregon Health and Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01313624     History of Changes
Other Study ID Numbers: GS-US-219-0101
First Posted: March 14, 2011    Key Record Dates
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases