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

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

June 30, 2009

Study Completion Date

August 31, 2009

Conditions
Cystic FibrosisLung InfectionPseudomonas Aeruginosa
Interventions
DRUG

AZLI 75 mg three times daily (TID)

DRUG

Placebo three times daily (TID)

Trial Locations (40)

Unknown

Phoenix Children's Hospital, Phoenix

University Medical Center, Tucson

Arkansas Children's Hospital, Little Rock

University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine, Little Rock

Kaiser Permanente, Oakland

Children's Hospital of Orange County, Orange

The Children's Hospital, Aurora

Connecticut Children's Medical Center, Hartford

Nemours Children's Clinic, Jacksonville

Nemours Children's Clinic, Orlando

Children's Memorial Hospital, Chicago

Indiana University, Outpatient Clinical Research Facility, Indianapolis

James Whitcomb Riley Hospital for Children, Indianapolis

Children's Hospital, Boston, Boston

Tufts Medical Center, Pediatric Pulmonary Clinic, Boston

University of Michigan Health System, Ann Arbor

The Children's Hospital of Michigan, Detroit Medical Center, Detroit

The Minnesota CF Center, University of Minnesota Medical Center, Minneapolis

Children's Lung Specialists, Las Vegas

Albany Medical College, Albany

The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo, Buffalo

Long Island Jewish Medical Center, New Hyde Park

SUNY Upstate Medical University, Syracuse

Cincinnati Children's Hospital Medical Center, Cincinnati

Nationwide Children's Hospital, Columbus

Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center, Toledo

Santiago Reyes, MD, Oklahoma City

Penn State Milton S. Hershey Medical Center, Hershey

Drexel University College of Medicine, Pulmonary Associates, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

St. Christopher's Hospital for Children, Philadelphia

Baylor College of Medicine, Houston

Primary Children's Medical Center, Salt Lake City

Children's Hospital and Regional Medical Center, Seattle

Department of Respiratory Medicine, The Children's Hospital at Westmead, Westmead

Department of Respiratory Medicine, Westmead Hospital, Westmead

The Prince Charles Hospital, Adult Cystic Fibrosis Centre, Chermside

Respiratory Medicine, Royal Children's Hospital, Herston

Child and Adolescent Health Services, Princess Margaret Hospital, Perth

Centre de Recherche du CHUM, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT00712166 - Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa | Biotech Hunter | Biotech Hunter