This study is to investigate whether using a continuous alternating therapy (CAT) regimen of
2 antibiotics of different classes and with different mechanisms of action may provide the
clinical benefits of reducing acute pulmonary exacerbations, maintaining lung function, and
controlling respiratory symptoms for cystic fibrosis (CF) patients while minimizing the risk
of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains.
After screening, eligible participants will be enrolled into the study and begin a 28-day
run in period of tobramycin inhalation solution (TIS) twice daily. After the run-in,
participants will return to the clinic and be randomized to either the Aztreonam for
Inhalation Solution (AZLI) arm or the placebo arm. The AZLI arm has 3 cycles of AZLI three
times daily for 28 days alternating with TIS twice daily for 28 days. The placebo arm has 3
cycles of placebo three times daily for 28 days alternating with 3 cycles of TIS twice daily
for 28 days. Participants will return to the clinic for evaluation after each cycle of
antibiotics for evaluation. There will be 9 scheduled study visits per participant.
Minimum age: 6 Years.
Maximum age: N/A.
Gender(s): Both.
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Phoenix Children's Hospital, Phoenix, Arizona 85016, United States
University of California - San Diego, La Jolla, California 92093, United States
Children's Hospital Los Angeles, Los Angeles, California 90027, United States
Kaiser Permanente Medical Center, Oakland, California 94611, United States
National Jewish Health, Denver, Colorado 80206, United States
Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States
Children's National Medical Center, Washington DC, District of Columbia 20010, United States
Central Florida Pulmonary Group, Altamonte Springs, Florida 32701, United States
University of Florida, Gainesville, Florida 32610, United States
South Broward Hospital dba Memorial Healthcare System, Hollywood, Florida 33021, United States
Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207, United States
University of Miami, Miami, Florida 33136, United States
Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States
Nemours Children's Clinic - Orlando, Orlando, Florida 32801, United States
Nemour's Children's Clinic, Pensacola, Florida 32504, United States
All Children's Hospital, St. Petersburg, Florida 33701, United States
Tampa General Hospital, Tampa, Florida 33606, United States
Emory Cystic Fibrosis Center, Atlanta, Georgia 30084, United States
Georgia Health, Augusta, Georgia 30912, United States
St. Lukes Medical Center, Boise, Idaho 37012, United States
University of Chicago, Chicago, Illinois 60637, United States
Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure, Glenview, Illinois 60025, United States
Indiana University, Indianapolis, Indiana 46202, United States
Riley Hospital for Children, Indianapolis, Indiana 46202, United States
University of Kansas Medical Center, Kansas City, Kansas 66160, United States
Maine Medical Center, Portland, Maine 38103, United States
Boston Children's Hospital, Boston, Massachusetts 02115, United States
University of Michigan, Ann Arbor, Michigan 48109, United States
Harper University Hospital, Detroit, Michigan 48201, United States
Spectrum Health - Helen DeVos Children's Hospital, Grand Rapids, Michigan 49503, United States
University of Mississippi Medical Center, Jackson, Mississippi 39216, United States
St. Louis University - Cardinal Glennon Children's Hospital, St. Louis, Missouri 63104, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Children's Lung Specialists, Las Vegas, Nevada 89107, United States
Dartmouth Hitchcock Specialty Care Clinic, Bedford, New Hampshire 03110, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States
Morristown Medical Center, Morristown, New Jersey 07962, United States
UNM Clinical and Translational Center, Albuquerque, New Mexico 87131, United States
Albany Medical College, Albany, New York 12208, United States
Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center, New Hyde Park, New York 11042, United States
Gunnar Esiason Adult CF and Lung Program, New York, New York 10032, United States
SUNY Upstate University, Syracuse, New York 13210, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Akron Children's Hospital, Akron, Ohio 44308, United States
Cincinnati Children's Hospital, Cincinnati, Ohio 45229, United States
UC Health - University of Cincinnati, Cincinnati, Ohio 45267, United States
The Toledo Hospital/Toledo Children's Hospital CF Center, Toledo, Ohio 43606, United States
OU Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Santiago Reyes, MD, Oklahoma City, Oklahoma 73112, United States
Geisinger Clinic, Danville, Pennsylvania 17822, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States
Drexel University College of Medicine, Philadelphia, Pennsylvania 19107, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
East Tennessee Children's Hospital, Knoxville, Tennessee 37916, United States
University of Tennessee Medical Center, Knoxville, Tennessee 37920, United States
Children's Foundation Research Institute/UTHSC, Memphis, Tennessee 28103, United States
Vanderbilt Children's Hospital, Nashville, Tennessee 37232, United States
Austin Children's Chest Associates, Austin, Texas 78723, United States
UT Southwestern Medical Center, Dallas, Texas 75390, United States
Cook Children's Medical Center, Ft. Worth, Texas 76104, United States
Alamo Clinical Research Associates, San Antonio, Texas 78212, United States
University of Utah, Salt Lake City, Utah 84132, United States
Vermont Lung Center at the University of Vermont, Colchester, Vermont 05446, United States
University of Virginia, Charlottesville, Virginia 22908, United States
Children's Hospital of the King's Daughters, Norfolk, Virginia 23510, United States
VCU Children's Hospital, Richmond, Virginia 23298, United States
West Virginia University, Morgantown, West Virginia 26506, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States