Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
- Registration Number
- NCT01314716
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZLI-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. Placebo-AZLI 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. Placebo-AZLI Placebo 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.
- Primary Outcome Measures
Name Time Method Change in QOL-B Respiratory Symptoms Score at Day 28 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
Name Time Method Change in QOL-B Respiratory Symptoms Score at Day 84 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.
Time to Protocol-Defined Exacerbation (PDE) 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
Trial Locations
- Locations (85)
Kelowna Respiratory Research and Allergy Clinic
🇨🇦Kelowna, British Columbia, Canada
The Lung Centre at Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
University of Florida
🇺🇸Jacksonville, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
UC San Diego Medical Center
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
CHU Toulouse - Hôpital Larrey
🇫🇷Toulouse, France
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
St Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Florence Research Associates
🇺🇸Florence, Alabama, United States
Hôpital Pasteur, CHU de Nice
🇫🇷Nice, France
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Clinical Trials Connection
🇺🇸Flagstaff, Arizona, United States
AZ Pulmonary Specialists, LTD
🇺🇸Scottsdale, Arizona, United States
Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
🇺🇸Orange, California, United States
Florida Premier Research Institute
🇺🇸Winter Park, Florida, United States
Pulmonary & Critical Care Associates of Baltimore
🇺🇸Rosedale, Maryland, United States
CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP
🇫🇷Gap, PACA, France
CUB Hôpital Erasme
🇧🇪Brussels, Belgium
University of Utah
🇺🇸Salt Lake City, Utah, United States
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
KUL UZ Gasthuisberg
🇧🇪Leuven, Belgium
Pulmonary Consultants, PLLC
🇺🇸Tacoma, Washington, United States
Charite Campus Virchow-Klinikum
🇩🇪Berlin, Germany
CHU de Montpellier-Hopital Arnaud de Villeneuve
🇫🇷Montpellier Cedex 05, France
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Research Center for Medical Studies (RCMS)
🇩🇪Berlin-Charlottenburg (Westend), Germany
University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
The Oregon Clinic P.C./ Pulmonary Division
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
Hospital Vall d´Hebrón
🇪🇸Barcelona, Spain
Klinikum Innenstadt der LMU Munchen
🇩🇪Munich, Germany
S.Anna Hospital, University of Ferrara
🇮🇹Ferrara, Italy
GBS RE Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Torbay District General Hospital
🇬🇧Torquay, Devon, United Kingdom
University of Modena and Reggio Emilia
🇮🇹Modena, Italy
Azienda Universitaria Federico II
🇮🇹Naples, Italy
University Hospital Giessen
🇩🇪Giessen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Papworth Hospital NHS Trust
🇬🇧Cambridgeshire, United Kingdom
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord
🇫🇷Marseille, France
Repatriation General Hospital
🇦🇺Daw Park, South Australia, Australia
Hopital Haut-Leveque
🇫🇷Pessac, France
Universitätsklinikum Jena Clinic for Internal Medicine II
🇩🇪Jena, Germany
POIS Leipzig GbR
🇩🇪Leipzig, Germany
UO Broncopneumologia IRCCS Fondazione Cà Granda Milano
🇮🇹Milan, Italy
Medisch Centrum Alkmaar
🇳🇱Alkmaar, Netherlands
Royal Wolverhampton Hospitals NHS Trust
🇬🇧Wolverhampton, United Kingdom
Erasmus MC
🇳🇱Rotterdam, Netherlands
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital La Fe
🇪🇸Valencia, Spain
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
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
Southeastern Lung Care PC
🇺🇸Decatur, Georgia, United States
Phoenix Medical Group
🇺🇸Peoria, Arizona, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Sarasota Memorial Hospital - Clinical Research Center
🇺🇸Sarasota, Florida, United States
Central Florida Pulmonary Group
🇺🇸Orlando, Florida, United States
Loess Hills Clinical Research
🇺🇸Council Bluffs, Iowa, 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
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Columbia University, NY Presbyterian Hospital
🇺🇸New York, New York, United States
Royal Perth Hospital
🇦🇺Perth, New South Wales, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Burnside War Memorial Hospital Pharmacy
🇦🇺Toorak Gardens, South Australia, Australia
Università di Pisa - Ospedale Cisanello
🇮🇹Pisa, Italy
Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica
🇮🇹Verona, Italy
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Pasadena Center for Medical Research
🇺🇸St. Petersburg, Florida, United States
Univ.-Klinikum Leipzig, Innere Med.
🇩🇪Leipzig, Germany
Concord Hospital
🇦🇺Concord, New South Wales, Australia
Tampa General Hospital - New Lung Associates
🇺🇸Tampa, Florida, United States