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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01641822
Other study ID # GS-US-205-0170
Secondary ID
Status Completed
Phase Phase 3
First received July 13, 2012
Last updated April 9, 2015
Start date November 2012
Est. completion date January 2015

Study information

Verified date April 2015
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility Inclusion Criteria:

- Confirmed diagnosis of CF

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

- 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Aztreonam for Inhalation Solution (AZLI)
75 mg (1 ml) of aztreonam, supplied as Aztreonam for Inhalation Solution (AZLI) administered three times a day for 28 days per course.
Placebo
Sugar solution for inhalation administered three times a day for 28 days per course.

Locations

Country Name City State
United States Akron Children's Hospital Akron Ohio
United States Albany Medical College Albany New York
United States UNM Clinical and Translational Center Albuquerque New Mexico
United States Central Florida Pulmonary Group Altamonte Springs Florida
United States University of Michigan Ann Arbor Michigan
United States Emory Cystic Fibrosis Center Atlanta Georgia
United States Georgia Health Augusta Georgia
United States Austin Children's Chest Associates Austin Texas
United States Dartmouth Hitchcock Specialty Care Clinic Bedford New Hampshire
United States University of Alabama at Birmingham Birmingham Alabama
United States St. Lukes Medical Center Boise Idaho
United States Boston Children's Hospital Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Charlottesville Virginia
United States University of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Cincinnati Ohio
United States UC Health - University of Cincinnati Cincinnati Ohio
United States Vermont Lung Center at the University of Vermont Colchester Vermont
United States UT Southwestern Medical Center Dallas Texas
United States Geisinger Clinic Danville Pennsylvania
United States National Jewish Health Denver Colorado
United States Harper University Hospital Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Cook Children's Medical Center Ft. Worth Texas
United States University of Florida Gainesville Florida
United States Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure Glenview Illinois
United States Spectrum Health - Helen DeVos Children's Hospital Grand Rapids Michigan
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States South Broward Hospital dba Memorial Healthcare System Hollywood Florida
United States Indiana University Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic - Jacksonville Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States East Tennessee Children's Hospital Knoxville Tennessee
United States University of Tennessee Medical Center Knoxville Tennessee
United States University of California - San Diego La Jolla California
United States Children's Lung Specialists Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Children's Hospital Los Angeles Los Angeles California
United States Children's Foundation Research Institute/UTHSC Memphis Tennessee
United States University of Miami Miami Florida
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States West Virginia University Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Vanderbilt Children's Hospital Nashville Tennessee
United States Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center New Hyde Park New York
United States Gunnar Esiason Adult CF and Lung Program New York New York
United States Children's Hospital of the King's Daughters Norfolk Virginia
United States Kaiser Permanente Medical Center Oakland California
United States OU Health Sciences Center Oklahoma City Oklahoma
United States Santiago Reyes, MD Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Arnold Palmer Hospital for Children Orlando Florida
United States Nemours Children's Clinic - Orlando Orlando Florida
United States Nemour's Children's Clinic Pensacola Florida
United States Drexel University College of Medicine Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Maine Medical Center Portland Maine
United States VCU Children's Hospital Richmond Virginia
United States University of Utah Salt Lake City Utah
United States Alamo Clinical Research Associates San Antonio Texas
United States St. Louis University - Cardinal Glennon Children's Hospital St. Louis Missouri
United States All Children's Hospital St. Petersburg Florida
United States SUNY Upstate University Syracuse New York
United States Tampa General Hospital Tampa Florida
United States The Toledo Hospital/Toledo Children's Hospital CF Center Toledo Ohio
United States Children's National Medical Center Washington DC District of Columbia
United States Alfred I. duPont Hospital for Children Wilmington Delaware

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of protocol-defined exacerbations from baseline through Week 24 24 weeks No
Secondary Average actual change from baseline in forced expiratory volume in 1 second (FEV1) % predicted at the end of each course of study drug FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. Weeks 4, 12 and 20 No
Secondary Time to first protocol-defined pulmonary exacerbation The time to first protocol-defined pulmonary exacerbation will be summarized using Kaplan-Meier (KM) summary statistics and analyzed using the log-rank test. Baseline to Week 24 No
Secondary Rate of hospitalizations for a respiratory event The rate of respiratory hospitalizations will be summarized and analyzed using negative binomial regression methods similar to the primary endpoint analysis. Total number of events will also be presented. Baseline to Week 24 No
Secondary 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) Baseline to Weeks 4, 12, and 20 No
Secondary Percent of subjects who use non-study IV or inhaled antibiotics for protocol-defined pulmonary exacerbations through Week 24 Baseline to Week 24 No
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