Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
NCT ID: NCT01641822
Last Updated: 2016-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2012-12-31
2015-01-31
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
Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI for 28 days followed by TIS for 28 days.
AZLI
Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer
Tobramycin inhalation solution
Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor
Placebo
Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS for 28 days.
Placebo to match AZLI
Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer
Tobramycin inhalation solution
Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor
Interventions
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AZLI
Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer
Placebo to match AZLI
Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer
Tobramycin inhalation solution
Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to screening
* Forced expiratory volume (FEV)1 ≥ 25 and ≤ 75% predicted
* History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory exacerbation in the 12 months prior to screening
Exclusion Criteria
* Concurrent hospitalization at enrollment
* History of local or systemic hypersensitivity to monobactams or aminoglycoside antibiotics or history of aminoglycoside antibiotic associated toxicity
6 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Bresnik, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California - San Diego
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente Medical Center
Oakland, California, United States
National Jewish Health
Denver, Colorado, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Central Florida Pulmonary Group
Altamonte Springs, Florida, United States
University of Florida
Gainesville, Florida, United States
South Broward Hospital dba Memorial Healthcare System
Hollywood, Florida, United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Nemour's Children's Clinic
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory Cystic Fibrosis Center
Atlanta, Georgia, United States
Georgia Health
Augusta, Georgia, United States
St. Lukes Medical Center
Boise, Idaho, United States
University of Chicago
Chicago, Illinois, United States
Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure
Glenview, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Maine Medical Center
Portland, Maine, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Harper University Hospital
Detroit, Michigan, United States
Spectrum Health - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis University - Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Children's Lung Specialists
Las Vegas, Nevada, United States
Dartmouth Hitchcock Specialty Care Clinic
Bedford, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
UNM Clinical and Translational Center
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center
New Hyde Park, New York, United States
Gunnar Esiason Adult CF and Lung Program
New York, New York, United States
SUNY Upstate University
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
UC Health - University of Cincinnati
Cincinnati, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital CF Center
Toledo, Ohio, United States
OU Health Sciences Center
Oklahoma City, Oklahoma, United States
Santiago Reyes, MD
Oklahoma City, Oklahoma, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Children's Foundation Research Institute/UTHSC
Memphis, Tennessee, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Austin Children's Chest Associates
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Alamo Clinical Research Associates
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Vermont Lung Center at the University of Vermont
Colchester, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
VCU Children's Hospital
Richmond, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Flume PA, Clancy JP, Retsch-Bogart GZ, Tullis DE, Bresnik M, Derchak PA, Lewis SA, Ramsey BW. Continuous alternating inhaled antibiotics for chronic pseudomonal infection in cystic fibrosis. J Cyst Fibros. 2016 Nov;15(6):809-815. doi: 10.1016/j.jcf.2016.05.001. Epub 2016 May 24.
Other Identifiers
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2015-000398-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-205-0170
Identifier Type: -
Identifier Source: org_study_id
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