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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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Aztreonam for Inhalation Solution (AZLI) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Mark Bresnik, MD, Study Director, Affiliation: Gilead Sciences


This study is to investigate whether using a continuous alternating therapy (CAT) regimen of 2 antibiotics of different classes and with different mechanisms of action may provide the clinical benefits of reducing acute pulmonary exacerbations, maintaining lung function, and controlling respiratory symptoms for cystic fibrosis (CF) patients while minimizing the risk of emergence of antibiotic-resistant Pseudomonas aeruginosa (PA) strains. After screening, eligible participants will be enrolled into the study and begin a 28-day run in period of tobramycin inhalation solution (TIS) twice daily. After the run-in, participants will return to the clinic and be randomized to either the Aztreonam for Inhalation Solution (AZLI) arm or the placebo arm. The AZLI arm has 3 cycles of AZLI three times daily for 28 days alternating with TIS twice daily for 28 days. The placebo arm has 3 cycles of placebo three times daily for 28 days alternating with 3 cycles of TIS twice daily for 28 days. Participants will return to the clinic for evaluation after each cycle of antibiotics for evaluation. There will be 9 scheduled study visits per participant.

Clinical Details

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Rate of protocol-defined exacerbations from baseline through Week 24

Secondary outcome:

Average actual change from baseline in forced expiratory volume in 1 second (FEV1) % predicted at the end of each course of study drug

Time to first protocol-defined pulmonary exacerbation

Rate of hospitalizations for a respiratory event

Average change from baseline in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Symptom Scale (RSS) score at the end of each course of study drug (Weeks 4, 12, and 20)

Percent of subjects who use non-study IV or inhaled antibiotics for protocol-defined pulmonary exacerbations through Week 24


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Confirmed diagnosis of CF

- Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to


- FEV1 ≥25 and ≤ 75% predicted

- History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory

exacerbation in the 12 months prior to screening Exclusion Criteria:

- Concurrent use of oral, IV or inhaled antibiotics at enrollment

- Concurrent hospitalization at enrollment

- History of local or systemic hypersensitivity to monobactams or aminoglycoside

antibiotics or history of aminoglycoside antibiotic associated toxicity

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States

University of California - San Diego, La Jolla, California 92093, United States

Children's Hospital Los Angeles, Los Angeles, California 90027, United States

Kaiser Permanente Medical Center, Oakland, California 94611, United States

National Jewish Health, Denver, Colorado 80206, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington DC, District of Columbia 20010, United States

Central Florida Pulmonary Group, Altamonte Springs, Florida 32701, United States

University of Florida, Gainesville, Florida 32610, United States

South Broward Hospital dba Memorial Healthcare System, Hollywood, Florida 33021, United States

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207, United States

University of Miami, Miami, Florida 33136, United States

Arnold Palmer Hospital for Children, Orlando, Florida 32806, United States

Nemours Children's Clinic - Orlando, Orlando, Florida 32801, United States

Nemour's Children's Clinic, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

Tampa General Hospital, Tampa, Florida 33606, United States

Emory Cystic Fibrosis Center, Atlanta, Georgia 30084, United States

Georgia Health, Augusta, Georgia 30912, United States

St. Lukes Medical Center, Boise, Idaho 37012, United States

University of Chicago, Chicago, Illinois 60637, United States

Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure, Glenview, Illinois 60025, United States

Indiana University, Indianapolis, Indiana 46202, United States

Riley Hospital for Children, Indianapolis, Indiana 46202, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Maine Medical Center, Portland, Maine 38103, United States

Boston Children's Hospital, Boston, Massachusetts 02115, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

Harper University Hospital, Detroit, Michigan 48201, United States

Spectrum Health - Helen DeVos Children's Hospital, Grand Rapids, Michigan 49503, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States

St. Louis University - Cardinal Glennon Children's Hospital, St. Louis, Missouri 63104, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Children's Lung Specialists, Las Vegas, Nevada 89107, United States

Dartmouth Hitchcock Specialty Care Clinic, Bedford, New Hampshire 03110, United States

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Morristown Medical Center, Morristown, New Jersey 07962, United States

UNM Clinical and Translational Center, Albuquerque, New Mexico 87131, United States

Albany Medical College, Albany, New York 12208, United States

Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center, New Hyde Park, New York 11042, United States

Gunnar Esiason Adult CF and Lung Program, New York, New York 10032, United States

SUNY Upstate University, Syracuse, New York 13210, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Akron Children's Hospital, Akron, Ohio 44308, United States

Cincinnati Children's Hospital, Cincinnati, Ohio 45229, United States

UC Health - University of Cincinnati, Cincinnati, Ohio 45267, United States

The Toledo Hospital/Toledo Children's Hospital CF Center, Toledo, Ohio 43606, United States

OU Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Santiago Reyes, MD, Oklahoma City, Oklahoma 73112, United States

Geisinger Clinic, Danville, Pennsylvania 17822, United States

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Drexel University College of Medicine, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

East Tennessee Children's Hospital, Knoxville, Tennessee 37916, United States

University of Tennessee Medical Center, Knoxville, Tennessee 37920, United States

Children's Foundation Research Institute/UTHSC, Memphis, Tennessee 28103, United States

Vanderbilt Children's Hospital, Nashville, Tennessee 37232, United States

Austin Children's Chest Associates, Austin, Texas 78723, United States

UT Southwestern Medical Center, Dallas, Texas 75390, United States

Cook Children's Medical Center, Ft. Worth, Texas 76104, United States

Alamo Clinical Research Associates, San Antonio, Texas 78212, United States

University of Utah, Salt Lake City, Utah 84132, United States

Vermont Lung Center at the University of Vermont, Colchester, Vermont 05446, United States

University of Virginia, Charlottesville, Virginia 22908, United States

Children's Hospital of the King's Daughters, Norfolk, Virginia 23510, United States

VCU Children's Hospital, Richmond, Virginia 23298, United States

West Virginia University, Morgantown, West Virginia 26506, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States

Additional Information

Starting date: November 2012
Last updated: April 9, 2015

Page last updated: August 23, 2015

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