Status:
UNKNOWN
Observational Trial of the Longitudinal Effects of CFTR Modulator Drugs
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Brief Summary
CF patients enrolled in this protocol will be recruited from patients followed by the Adult CF Program at National Jewish Health. Patients will be selected based on planned use of a CFTR modulator by ...
Eligibility Criteria
Inclusion
- Documented diagnosis of CF with an eligible mutation for modulator treatment.
- Age 18 years old or older.
- Patient is starting a CFTR modulator as part of their clinical care or switching CFTR modulator therapy agents, pending FDA approval.
- Ability to perform reproducible Pulmonary Function Tests.
- Willingness to comply with study procedure and willingness to provide written consent.
Exclusion
- • Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04353752
Start Date
September 16 2019
End Date
December 1 2025
Last Update
September 30 2022
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206