Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

September 30, 2011

Study Completion Date

January 31, 2012

Conditions
Cystic FibrosisBurkholderia Infections
Interventions
DRUG

AZLI

Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer.

DRUG

Placebo

Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer.

Trial Locations (35)

11040

New Hyde Park

15201

Pittsburgh

17033

Hershey

19104

Philadelphia

19803

Wilmington

23298

Richmond

26506

Morgantown

27599

Chapel Hill

29203

Columbia

29425

Charleston

32207

Jacksonville

33136

Miami

33606

Tampa

36608

Mobile

43205

Columbus

43606

Toledo

44308

Akron

48201

Detroit

53201

Milwaukee

55455

Minneapolis

60025

Glenview

63110

St Louis

72205

Little Rock

73112

Oklahoma City

80206

Denver

85016

Phoenix

87131

Albuquerque

89107

Las Vegas

97239

Portland

06102

Hartford

02115

Boston

01605

Worcester

07962

Morristown

08903

New Brunswick

M5B 1W8

Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01059565 - Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection | Biotech Hunter | Biotech Hunter