Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF

PHASE3CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Cystic Fibrosis
Interventions
DRUG

AZLI

Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer

DRUG

Placebo to match AZLI

Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer

DRUG

Tobramycin inhalation solution

Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor

Trial Locations (71)

10032

Gunnar Esiason Adult CF and Lung Program, New York

11042

Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center, New Hyde Park

12208

Albany Medical College, Albany

13210

SUNY Upstate University, Syracuse

15224

Children's Hospital of Pittsburgh, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

17822

Geisinger Clinic, Danville

19104

University of Pennsylvania, Philadelphia

19107

Drexel University College of Medicine, Philadelphia

19803

Alfred I. duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

22908

University of Virginia, Charlottesville

23298

VCU Children's Hospital, Richmond

23510

Children's Hospital of the King's Daughters, Norfolk

26506

West Virginia University, Morgantown

27710

Duke University Medical Center, Durham

28103

Children's Foundation Research Institute/UTHSC, Memphis

29425

Medical University of South Carolina, Charleston

30084

Emory Cystic Fibrosis Center, Atlanta

30912

Georgia Health, Augusta

32207

Nemours Children's Clinic - Jacksonville, Jacksonville

32504

Nemour's Children's Clinic, Pensacola

32610

University of Florida, Gainesville

32701

Central Florida Pulmonary Group, Altamonte Springs

32801

Nemours Children's Clinic - Orlando, Orlando

32806

Arnold Palmer Hospital for Children, Orlando

33021

South Broward Hospital dba Memorial Healthcare System, Hollywood

33136

University of Miami, Miami

33606

Tampa General Hospital, Tampa

33701

All Children's Hospital, St. Petersburg

35233

University of Alabama at Birmingham, Birmingham

37012

St. Lukes Medical Center, Boise

37232

Vanderbilt Children's Hospital, Nashville

37916

East Tennessee Children's Hospital, Knoxville

37920

University of Tennessee Medical Center, Knoxville

38103

Maine Medical Center, Portland

39216

University of Mississippi Medical Center, Jackson

43606

The Toledo Hospital/Toledo Children's Hospital CF Center, Toledo

44308

Akron Children's Hospital, Akron

45229

Cincinnati Children's Hospital, Cincinnati

45267

UC Health - University of Cincinnati, Cincinnati

46202

Indiana University, Indianapolis

Riley Hospital for Children, Indianapolis

48109

University of Michigan, Ann Arbor

48201

Harper University Hospital, Detroit

49503

Spectrum Health - Helen DeVos Children's Hospital, Grand Rapids

53201

Children's Hospital of Wisconsin, Milwaukee

60025

Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure, Glenview

60637

University of Chicago, Chicago

63104

St. Louis University - Cardinal Glennon Children's Hospital, St Louis

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

73104

OU Health Sciences Center, Oklahoma City

73112

Santiago Reyes, MD, Oklahoma City

75390

UT Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

78212

Alamo Clinical Research Associates, San Antonio

78723

Austin Children's Chest Associates, Austin

80206

National Jewish Health, Denver

84132

University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

87131

UNM Clinical and Translational Center, Albuquerque

89107

Children's Lung Specialists, Las Vegas

90027

Children's Hospital Los Angeles, Los Angeles

92093

University of California - San Diego, La Jolla

94611

Kaiser Permanente Medical Center, Oakland

02115

Boston Children's Hospital, Boston

03110

Dartmouth Hitchcock Specialty Care Clinic, Bedford

03756

Dartmouth Hitchcock Medical Center, Lebanon

07962

Morristown Medical Center, Morristown

05446

Vermont Lung Center at the University of Vermont, Colchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY