CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
NCT ID: NCT03350828
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
5000 participants
OBSERVATIONAL
2018-01-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Enrolled in the CFFPR
3. Male or female ≥ 4 months of age on day of study visit
4. Diagnosis of CF.
5. Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
6. Able to perform the testing and procedures required for this study, as judged by the investigator
1. Male or female ≥ 6 years of age on day of study visit.
2. Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
3. Last dose of elexacaftor/tezacaftor/ivacaftor taken at least 24hours and last dose of ivacaftor taken at least 12 hours prior to trough blood draw on day of visit.
Exclusion Criteria
2. Currently enrolled in an investigational trial (including open-label follow-on studies and Early Access Programs (EAP) of an agent expected to have an impact on sweat chloride (refer to current list provided on study website)
4 Months
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Nicole Hamblett
OTHER
Responsible Party
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Nicole Hamblett
Professor in the Department of Pediatrics in the Division of Pulmonary Medicine
Principal Investigators
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Edith Zemanick, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Michael Konstan, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Nicole Mayer-Hamblett, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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The Children's Hospital Alabama, University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, 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
Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, 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
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
The Cystic Fibrosis Center of Western New York
Buffalo, New York, United States
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Toledo Children's Hospital
Toledo, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee CF Care and Research Center
Memphis, Tennessee, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Primary Children's 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
West Virginia University - Morgantown
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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VanDevanter DR, Zemanick ET, Konstan MW, Ren CL, Odem-Davis K, Emerman I, Young J, Mayer-Hamblett N; CHEC-SC Study Group. Willingness of people with cystic fibrosis receiving elexacaftor/tezacaftor/ivacaftor (ETI) to participate in randomized modulator and inhaled antimicrobial clinical trials. J Cyst Fibros. 2023 Jul;22(4):652-655. doi: 10.1016/j.jcf.2023.04.007. Epub 2023 Apr 24.
Other Identifiers
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CHEC-OB-17
Identifier Type: -
Identifier Source: org_study_id
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