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

Last updated: March 7, 2014
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Bronchiectasis

Treatment

N/A

Clinical Study ID

NCT01314716
GS-US-219-0104
  • Ages > 18
  • All Genders

Study Summary

The AIR-BX2 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.

Eligibility Criteria

Inclusion

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

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 withactivity and at night was allowed)

  • Treatment for nontuberculous mycobacteria infection or active mycobacteriumtuberculosis infection within 1 year of enrollment

  • Other serious medical conditions.

Study Design

Total Participants: 274
Study Start date:
April 01, 2011
Estimated Completion Date:
July 31, 2013

Connect with a study center

  • Concord Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • St Vincent's Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, New South Wales 6000
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Mater Adult Hospital

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Repatriation General Hospital

    Daw Park, South Australia 5041
    Australia

    Site Not Available

  • Burnside War Memorial Hospital Pharmacy

    Toorak Gardens, South Australia 5065
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peninsula Heallth

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • CUB Hôpital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • KUL UZ Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • Kelowna Respiratory Research and Allergy Clinic

    Kelowna, British Columbia V1W 1V3
    Canada

    Site Not Available

  • The Lung Centre at Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP

    Gap, PACA, 05007 Cedex
    France

    Site Not Available

  • Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord

    Marseille, 13015
    France

    Site Not Available

  • CHU de Montpellier-Hopital Arnaud de Villeneuve

    Montpellier Cedex 05, 34295
    France

    Site Not Available

  • Hôpital Pasteur, CHU de Nice

    Nice, 6002
    France

    Site Not Available

  • Hopital Haut-Leveque

    Pessac, 33604
    France

    Site Not Available

  • CHU Toulouse - Hôpital Larrey

    Toulouse, 31054 cedex 9
    France

    Site Not Available

  • Charite Campus Virchow-Klinikum

    Berlin, 12200
    Germany

    Site Not Available

  • Research Center for Medical Studies (RCMS)

    Berlin-Charlottenburg (Westend), 14052
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • University Hospital Giessen

    Giessen, 35392
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes

    Homburg, 66421
    Germany

    Site Not Available

  • Universitätsklinikum Jena Clinic for Internal Medicine II

    Jena, 07747
    Germany

    Site Not Available

  • POIS Leipzig GbR

    Leipzig, 04357
    Germany

    Site Not Available

  • Univ.-Klinikum Leipzig, Innere Med.

    Leipzig, 04103
    Germany

    Site Not Available

  • Klinikum Innenstadt der LMU Munchen

    Munich, 80336
    Germany

    Site Not Available

  • S.Anna Hospital, University of Ferrara

    Ferrara, 44121
    Italy

    Site Not Available

  • UO Broncopneumologia IRCCS Fondazione Cà Granda Milano

    Milan, 20122
    Italy

    Site Not Available

  • University of Modena and Reggio Emilia

    Modena, 41100
    Italy

    Site Not Available

  • Azienda Universitaria Federico II

    Naples, 80131
    Italy

    Site Not Available

  • Università di Pisa - Ospedale Cisanello

    Pisa, 56124
    Italy

    Site Not Available

  • Ospedali Riuniti Di Trieste- Ospedale Cattinara

    Trieste, 34100
    Italy

    Site Not Available

  • Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica

    Verona, 37124
    Italy

    Site Not Available

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • VU University Medical Center

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015GD
    Netherlands

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Vall d´Hebrón

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Josep Trueta

    Girona, 17007
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital La Fe

    Valencia, 46009
    Spain

    Site Not Available

  • Papworth Hospital NHS Trust

    Cambridgeshire, CB23 3RE
    United Kingdom

    Site Not Available

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital, NHS Foundation Trust

    Exeter, EX5 5AN
    United Kingdom

    Site Not Available

  • Sir William Leech Centre for Lung Research, Freeman Hospital

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • GBS RE Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, 532 1DA
    United Kingdom

    Site Not Available

  • Torbay District General Hospital

    Torquay, Devon, TQ2 7AA
    United Kingdom

    Site Not Available

  • Royal Wolverhampton Hospitals NHS Trust

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

  • Florence Research Associates

    Florence, Alabama 35630
    United States

    Site Not Available

  • Clinical Trials Connection

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Phoenix Medical Group

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Pulmonary Associates

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • AZ Pulmonary Specialists, LTD

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

    Orange, California 92780
    United States

    Site Not Available

  • UC San Diego Medical Center

    San Diego, California 92103
    United States

    Site Not Available

  • California Pacific Medical Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • University of Florida

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Central Florida Pulmonary Group

    Orlando, Florida 32803
    United States

    Site Not Available

  • Sarasota Memorial Hospital - Clinical Research Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Pasadena Center for Medical Research

    St. Petersburg, Florida 33707
    United States

    Site Not Available

  • Tampa General Hospital - New Lung Associates

    Tampa, Florida 33606
    United States

    Site Not Available

  • Florida Premier Research Institute

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Southeastern Lung Care PC

    Decatur, Georgia 30033
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Loess Hills Clinical Research

    Council Bluffs, Iowa 51503
    United States

    Site Not Available

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Pulmonary & Critical Care Associates of Baltimore

    Rosedale, Maryland 21237
    United States

    Site Not Available

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Pulmonary & Allergy Associates, P.A.

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Jamaica Hospital Medical Center

    Jamaica, New York 11418
    United States

    Site Not Available

  • Columbia University, NY Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • UNC Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • The Oregon Clinic P.C./ Pulmonary Division

    Portland, Oregon 97220
    United States

    Site Not Available

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • University of Texas Health Science Center at Tyler

    Tyler, Texas 75708
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Pulmonary Consultants, PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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