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CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes (the CHEC-SC Study)

Official Title: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes (the CHEC-SC Study)

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.

Eligible subjects who have been prescribed and chronically taking a commercially approved CFTR modulator for at least 3 months will be enrolled for a single visit to collect sweat to be analyzed for SC at their local site laboratory. Limited clinical data obtained at this visit will be augmented by retrospective and prospective data obtained from the Cystic Fibrosis Foundation Patient Registry (CFFPR). Study subjects who have been prescribed and switch to an alternative commercially approved CFTR modulator will be approached to re-enroll in the study after being on the alternative modulator for at least 3 months so that a new SC value can be obtained.

NCT03350828
McColley, Susanna, MD
Observational
Yes

Contact Information:

Larissa Rugg

Clinical Research Coordinator

312-227-6865