304
Participants
Start Date
September 30, 2004
Primary Completion Date
June 30, 2009
Study Completion Date
August 31, 2009
Tobramycin solution for inhalation (TOBI)
Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa.
Oral placebo
Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily.
Oral ciprofloxacin
Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.
New York Medical College, Valhalla
Albany Medical College, Albany
State University of New York Upstate Medical University, Syracuse
University of Rochester, Rochester
Children's Hospital of Pittsburgh, Pittsburgh
Penn State Milton S. Hershey Medical Center, Hershey
duPont Hospital for Children, Wilmington
Johns Hopkins University, Baltimore
University of Virginia, Charlottesville
University of North Carolina, Chapel Hill, Chapel Hill
Emory University Cystic Fibrosis Center, Atlanta
Medical College of Georgia, Augusta
Nemours Children's Clinic, Jacksonville
All Children's Hospital Cystic Fibrosis Center, St. Petersburg
University of Alabama at Birmingham, Birmingham
LeBonheur Children's Medical Center, Memphis
University of Mississippi Medical Center, Jackson
Children's Hospital, Columbus
Rainbow Babies & Children's Hospital, Cleveland
Children's Hospital Medical Center of Akron, Akron
Children's Medical Center, Dayton
Riley Hospital/Indiana University, Indianapolis
Children's Hospital of Michigan, Detroit
Spectrum Health Hospitals - DeVos Children's, Grand Rapids
University of Iowa, Iowa City
Children's Hospital of Wisconsin, Milwaukee
University of Wisconsin Hospital and Clinics, Madison
Children's Hospitals & Clinics, Minneapolis
Children's Memorial Hospital, Chicago
Cardinal Glennon Children's Hospital, St Louis
Washington University School of Medicine, St Louis
Children's Mercy Hospital, Kansas City
Cook Children's Medical Center, Fort Worth
Texas Children's Hospital, Houston
Children's Hospital Denver, Aurora
University of Utah, Salt Lake City
Children's Hospital of Los Angeles, Los Angeles
University of California, San Francisco, San Francisco
Northern California Kaiser Cystic Fibrosis Center, Oakland
Oregon Health Sciences University, Portland
Children's Hospital & Regional Medical Center, Seattle
Stanford University, Palo Alto
University of Kentucky, Lexington
Maine Medical Center, Portland
Massachusetts General Hospital, Boston
Children's Hospital, Boston, Boston
University of Massachusetts Memorial Health Care, Worcester
University of Michigan, Ann Arbor
University of Nebraska, Omaha
Dartmouth-Hitchcock Medical Center, Lebanon
Monmouth Medical Center, Long Branch
St. Christopher's Hospital for Children, Philadelphia
Vanderbilt University Medical Center, Nashville
Vermont Children's Hospital at Fletcher Allen Health Care, Burlington
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cystic Fibrosis Foundation
OTHER
CF Therapeutics Development Network Coordinating Center
NETWORK
Seattle Children's Hospital
OTHER