Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT01314716
Last Updated: 2014-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2011-04-30
2013-07-31
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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Anne O'Donnell, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University Hospital
Locations
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Florence Research Associates
Florence, Alabama, United States
Clinical Trials Connection
Flagstaff, Arizona, United States
Phoenix Medical Group
Peoria, Arizona, United States
Pulmonary Associates
Phoenix, Arizona, United States
AZ Pulmonary Specialists, LTD
Scottsdale, Arizona, United States
Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
Orange, California, United States
UC San Diego Medical Center
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Sarasota Memorial Hospital - Clinical Research Center
Sarasota, Florida, United States
Pasadena Center for Medical Research
St. Petersburg, Florida, United States
Tampa General Hospital - New Lung Associates
Tampa, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Southeastern Lung Care PC
Decatur, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loess Hills Clinical Research
Council Bluffs, Iowa, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
Pulmonary & Critical Care Associates of Baltimore
Rosedale, Maryland, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Pulmonary & Allergy Associates, P.A.
Summit, New Jersey, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Columbia University, NY Presbyterian Hospital
New York, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
The Oregon Clinic P.C./ Pulmonary Division
Portland, Oregon, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Pulmonary Consultants, PLLC
Tacoma, Washington, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, United States
Concord Hospital
Concord, New South Wales, Australia
St Vincent's Hospital
Darlinghurst, 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
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Repatriation General Hospital
Daw Park, South Australia, Australia
Burnside War Memorial Hospital Pharmacy
Toorak Gardens, South Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
CUB Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
KUL UZ Gasthuisberg
Leuven, , Belgium
Kelowna Respiratory Research and Allergy Clinic
Kelowna, British Columbia, Canada
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP
Gap, PACA, , France
Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord
Marseille, , France
CHU de Montpellier-Hopital Arnaud de Villeneuve
Montpellier, , France
Hôpital Pasteur, CHU de Nice
Nice, , France
Hopital Haut-Leveque
Pessac, , France
CHU Toulouse - Hôpital Larrey
Toulouse, , France
Charite Campus Virchow-Klinikum
Berlin, , Germany
Research Center for Medical Studies (RCMS)
Berlin-Charlottenburg (Westend), , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
University Hospital Giessen
Giessen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Universitätsklinikum Jena Clinic for Internal Medicine II
Jena, , Germany
Univ.-Klinikum Leipzig, Innere Med.
Leipzig, , Germany
POIS Leipzig GbR
Leipzig, , Germany
Klinikum Innenstadt der LMU Munchen
Munich, , Germany
S.Anna Hospital, University of Ferrara
Ferrara, , Italy
UO Broncopneumologia IRCCS Fondazione Cà Granda Milano
Milan, , Italy
University of Modena and Reggio Emilia
Modena, , Italy
Azienda Universitaria Federico II
Naples, , Italy
Università di Pisa - Ospedale Cisanello
Pisa, , Italy
Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica
Verona, , Italy
Medisch Centrum Alkmaar
Alkmaar, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Hospital Vall d´Hebrón
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Josep Trueta
Girona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital La Fe
Valencia, , Spain
Papworth Hospital NHS Trust
Cambridgeshire, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Royal Devon and Exeter Hospital, NHS Foundation Trust
Exeter, , United Kingdom
Sir William Leech Centre for Lung Research, Freeman Hospital
Newcastle upon Tyne, , United Kingdom
GBS RE Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Torbay District General Hospital
Torquay, Devon, , United Kingdom
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, , United Kingdom
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-219-0104
Identifier Type: -
Identifier Source: org_study_id
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