Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
NCT ID: NCT02677701
Last Updated: 2021-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
119 participants
INTERVENTIONAL
2016-10-21
2020-02-13
Brief Summary
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Detailed Description
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This study will investigate how use of chronic oral azithromycin affects some of the previously demonstrated benefits to health when using inhaled tobramycin. The primary measurements will focus on lung function. Additional measurements will focus on disease-related quality of life as reported by subjects in the trial. Exploratory outcomes, including measurements of safety, are also planned.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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azithromycin
azithromycin 500mg tablet over-encapsulated to match placebo in appearance, taken by mouth thrice weekly for 6 weeks
azithromycin
500mg tablet over-encapsulated to match placebo
inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study
placebo
encapsulated placebo taken by mouth thrice weekly for 6 weeks
placebo (for azithromycin)
inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study
Interventions
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azithromycin
500mg tablet over-encapsulated to match placebo
placebo (for azithromycin)
inhaled tobramycin
clinically prescribed inhaled tobramycin used by subjects participating in the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* documented diagnosis of cystic fibrosis
* written informed consent (and assent when applicable)
* at least two respiratory cultures growing P. aeruginosa within the last 12 months
* FEV1% predicted between 25-100%
* use of at least two cycles of inhaled tobramycin within the last 24 weeks
* Off TISP and other inhaled anti-pseudomonal antibiotics for at least 2 weeks at Visit 1 and remain off of any inhaled antibiotics for an additional 2 weeks before starting inhaled tobramycin
* most recent liver function test results less than 4 times the upper limit of normal, obtained within the last 12 months
* prior or current use of azithromycin for at least four consecutive weeks
* stable clinical status and therapeutic regimen
Exclusion Criteria
* positive pregnancy test, lactating, or unwillingness to practice a pre-defined form of contraception, which includes abstinence
* inability to perform reproducible spirometry
* inability or unwillingness to cycle off of inhaled tobramycin for one 4-week period and without use of any additional inhaled antibiotics
* respiratory culture with Burkholderia cepacia complex species within 24 months or with nontuberculous mycobacteria within 18 months of screening
* use of intravenous or oral anti-pseudomonal antibiotics within 4 weeks of screening
* use of investigational therapy within 4 weeks of screening
* use of systemic corticosteroids equivalent to a daily dose more than 10mg of prednisone
* use of nelfinavir, warfarin, haloperidol, or methadone (concern of drug interaction with azithromycin)
* initiation of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy within 30 days
* ECG abnormality at screening requiring prompt further medical attention, or QTc interval \>480 msec for males and \>486 msec for females
* any other condition that, in the opinion of the site investigator, would compromise the safety of the subject or quality of the data
12 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cystic Fibrosis Foundation
OTHER
CF Therapeutics Development Network Coordinating Center
NETWORK
Seattle Children's Hospital
OTHER
Responsible Party
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David Nichols, MD
Associate Professor of Pediatrics
Principal Investigators
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David P Nichols, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Rady Children's Hospital and Health Center at the University of California San Diego
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
The Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Saint Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Saint Francis Medical Center
Peoria, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Maine Medical Partners Pediatric Specialty Care
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
The Minnesota Cystic Fibrosis Center
Minneapolis, Minnesota, United States
Children's Mercy Kansas City
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Beth Israel Medical Center
New York, New York, United States
Children's Hospital of New York
New York, New York, United States
University of Rochester Medical Center Strong Memorial
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NICHOL15A0
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TEACH-IP-15
Identifier Type: -
Identifier Source: org_study_id
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