Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa

PHASE3CompletedINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

September 30, 2006

Study Completion Date

September 30, 2006

Conditions
Cystic Fibrosis
Interventions
DRUG

AZLI 75 mg two times a day (BID)/three times a day (TID)

DRUG

Placebo two times a day (BID)/three times a day (TID)

Trial Locations (56)

Unknown

Phoenix Children's Hospital, Phoenix

University of Arkansas for Medical Sciences, Little Rock

University of California, San Diego, La Jolla

Children's Hospital Los Angeles, Los Angeles

Kaiser Permanente Medical Care Program, Oakland

Children's Hospital, Orange Co., Orange

Stanford University Hospital and Medical Center, Palo Alto

UC Davis Medical Center, Sacramento

Children's Hospital, Denver

Connecticut Children's Medical Center, Hartford

University of Florida Health Sciences Center, Gainesville

Nemours Children's Clinic, Jacksonville, Jacksonville

University of Miami School of Medicine, Miami

Nemours Children's Clinic, Orlando

Pediatric Pulmonary Associates, Florida, St. Petersburg

Emory Healthcare, Atlanta

Medical College of Georgia, Augusta

Children's Memorial Hospital/Northwestern University, Chicago

Chicago Children's Asthma Respiratory and Exercise Specialists, Glenview

Loyola University Medical Center, Maywood

North Suburban Pulmonary / Critical Care Consultants, Niles

Indiana University, Indianapolis

University of Kansas Medical Center, Kansas City

Maine Medical Center, Portland

Children's Hospital, Boston, Boston

Floating Hospital for Children, Boston

Massachusetts General Hospital, Boston

University of Michigan, Ann Arbor

Children's Hospital of Michigan/Wayne State University, Detroit

University of Minnesota, Minneapolis

Children's Lung Specialists, Ltd., Las Vegas

Morristown Memorial Hospital, Morristown

Albany Medical College, Albany

Long Island College Hospital, Brooklyn

Children's Hospital of Buffalo, Buffalo

Long Island Jewish Medical Center, New Hyde Park

Columbia University Medical Center, New York

State University of New York Stony Brook, Stony Brook

Children's Hospital of Westchester Medical Center/New York Medical College, Valhalla

Akron Children's Hospital, Akron

Columbus Children's Hospital, Ohio State University, Columbus

Children's Medical Center, Dayton

Dr. Santiago Reyes, Oklahoma City

Oregon Health & Science University, Portland

Penn State University Hershey Medical Center, Hershey

Drexel University College of Medicine, Philadelphia

St. Christopher's Hospital for Children, Philadelphia

Children's Hospital of Pittsburg, Pittsburgh

Rhode Island Hospital, Providence

Medical University of South Carolina, Charleston

Pediatric Pulmonary Associates, South Carolina, Columbia

Baylor College of Medicine, Houston

Alamo Clinical Research Associates, San Antonio

Pediatric Pulmonary Center, Richmond

Children's Hospital and Regional Medical Center, Seattle

West Virginia University, Morgantown

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00104520 - Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | Biotech Hunter | Biotech Hunter