Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT01313624
Last Updated: 2014-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2011-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
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.
AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
Placebo
Placebo to match AZLI administered via nebulizer three times daily
Interventions
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AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
Placebo
Placebo to match AZLI administered via nebulizer three times daily
Eligibility Criteria
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Inclusion Criteria
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Barker, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Pulmonary Associates
Phoenix, Arizona, United States
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center Heart and Lung Institute
Phoenix, Arizona, United States
Arizona Pulmonary Specialists
Scottsdale, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
Sacramento, California, United States
Landon Pediatric Foundation
Ventura, California, United States
National Jewish Health
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Bay Area Chest Physicians
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
Pulmonary Disease Specialists (PDS) Research
Kissimmee, Florida, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta Pulmonary Group
Atlanta, Georgia, United States
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Cardio Pulmonary Research at St. Luke's Hospital
Chesterfield, Missouri, United States
Albany Medical Center
Albany, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Winthrop University Hospital - Clinical Trials Center
Mineola, New York, United States
St. Luke's Roosevelt Hospital
New York, New York, United States
University of Cincinnati / UC Health
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
Philadelphia, Pennsylvania, United States
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Metroplex Pulmonary and Sleep Center
McKinney, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
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
Swedish Medical Center/Minor James Clinic
Seattle, Washington, United States
Multicare Pulmonary Specialist
Tacoma, Washington, United States
Concord Hospital
Concord, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, Australia
Royal Perth Hospital
Perth, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Adult Hospital
Brisbane, Queensland, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royla Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Daws Park, South Australia, Australia
Respiratory Clinical Trials
Toorak Gardens, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peninsula Health
Frankston, Victoria, Australia
Alfred Hospital
Westmead, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, Canada
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital Pacific Lung Research
Vancouver, British Columbia, Canada
Kingston General Hospital / Queen's University
Kingston, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Dr. Anil Dhar Private Practice
Windsor, Ontario, Canada
Centre Hospitalier de L'Université de Montréal Hotel Dieu
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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GS-US-219-0101
Identifier Type: -
Identifier Source: org_study_id
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