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

PHASE3CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

April 30, 2007

Study Completion Date

April 30, 2007

Conditions
Cystic Fibrosis
Interventions
DRUG

AZLI 75 mg three times a day (TID)

DRUG

Placebo three times a day (TID)

Trial Locations (53)

Unknown

University of Alabama at Birmingham, Birmingham

Pediatric Breathing Disorders Clinic, Anchorage

Phoenix Children's Hospital, Phoenix

University of Arkansas for Medical Sciences, Little Rock

Miller Children's Hospital, Long Beach

Children's Hospital, Los Angeles, Los Angeles

Children's Hospital of Orange County, Orange

Capital Allergy and Respiratory Disease Center, Sacramento

Yale New Haven Hospital, New Haven

University of Florida Health Sciences Center, Gainesville

Nemours Children's Clinic, Orlando, Orlando

Medical College of Georgia, Augusta

Children's Memorial Hospital / Northwestern University, Chicago

Riley Hospital for Children, Indianapolis

University of Iowa, Iowa City

Via Christi - St. Francis Regional Medical Center, Wichita

Tulane University Health Sciences Center, New Orleans

Louisiana State University Health Sciences Center, Shreveport

Central Maine Pulmonary Associates, Auburn

University of Michigan, Ann Arbor

University of Mississippi Medical Center, Jackson

University of Missouri, Columbia

St. Louis University, St Louis

Children's Lung Specialists, Las Vegas

St. Barnabas Healthcare System, Livingston

Albany Medical College, Albany

Long Island Jewish Medical Center, New Hyde Park

SUNY Upstate Medical University, Syracuse

University of North Carolina, Chapel Hill

Cincinnati Children's Hospital Medical Center, Cincinnati

University of Pennsylvania Health System, Philadelphia

Children's Hospital of Pittsburgh, Pittsburgh

Pediatric Pulmonary Associates, South Carolina, Columbia

Baylor Martha Foster Lung Care Center, Dallas

Alamo Clinical Research Associates, San Antonio

University of Utah, Salt Lake City

Naval Medical Center, Portsmouth

Pediatric Pulmonary Center/Virginia Commonwealth University, Richmond

University of Washington Medical Center, Seattle

University of Wisconsin, Madison

Children's Hospital at Westmead, Westmead

Westmead Hospital, Westmead

Royal Children's Hospital, Herston

Royal Adelaide Hospital, Adelaide

Alfred Hospital, Prahran

Sir Charles Gairdner Hospital, Nedlands

Princess Margaret Hospital for Children, Perth

Capital Health and the Governors of the University of Alberta, Edmonton

St. Paul's Hospital, Vancouver

Queen Elizabeth II Health Sciences Centre, Halifax

Brian Lyttle Professional Corporation, London

Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal

Auckland District Health Board, Auckland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY