CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

Running, not enrolling

Conditions studied: Cystic Fibrosis

In brief

This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic Fibrosis transmembrane conductance regulator (CFTR) modulator therapies.

Key facts

Study ID

NCT03350828

Run by

Nicole Hamblett

People needed

5000

Starts

2018-01-15

Expected to finish

2026-12-31

Last updated by the study team

2025-10-10

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
• Enrolled in the CFFPR
• Male or female ≥ 4 months of age on day of study visit
• Diagnosis of CF.
• Current treatment with a prescribed commercially approved CFTR modulator for at least 90 days prior to enrollment
• Able to perform the testing and procedures required for this study, as judged by the investigator
• Additional Inclusion Criteria for CHEC-PKPD Sub-Study:
• Male or female ≥ 6 years of age on day of study visit.
• Current treatment with elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to enrollment.
• 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.

You may not qualify if…

• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
• 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)

Where it is running

• 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
• The Children's Hospital Alabama, University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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