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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiectasis

Intervention: AZLI (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Alan Barker, MD, Principal Investigator, Affiliation: Oregon Health and Science University

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in QOL-B Respiratory Symptoms Score at Day 28

Secondary outcome:

Change in QOL-B Respiratory Symptoms Score at Day 84

Time to Protocol-Defined Exacerbation (PDE)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Calgary, Calgary, Alberta T2N 4N1, Canada

University of Alberta, Edmonton, Alberta T6G 2C8, Canada

Arizona Pulmonary Specialists, LTD, Phoenix, Arizona 85012, United States

Pulmonary Associates, Phoenix, Arizona 85006, 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

Kelowna Respiratory and Allergy Clinic, Kelowna, British Columbia V1W 1V3, Canada

St. Paul's Hospital Pacific Lung Research, Vancouver, British Columbia V6Z 1Y6, Canada

The Lung Centre at Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada

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

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

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

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

Oregon Health and Science University, Portland, Oregon 97239, United States

Asthma Allergy & Pulmonary Associates, Philadelphia, Pennsylvania 19107, 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

Centre Hospitalier de L'Université de Montréal Hotel Dieu, Montreal, Quebec H2W 1T8, Canada

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

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

Monash Medical Centre, Clayton, Victoria 3168, Australia

Peninsula Health, Frankston, Victoria 3199, Australia

Alfred Hospital, Westmead, Victoria 3194, Australia

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

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia

Additional Information

Starting date: April 2011
Last updated: March 7, 2014

Page last updated: August 20, 2015

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