Status:
UNKNOWN
Impact of Triple Combination CFTR Therapy on Sinus Disease.
Lead Sponsor:
Jennifer Taylor-Cousar
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-89 years
Brief Summary
The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.
Detailed Description
To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus...
Eligibility Criteria
Inclusion
- Subjects from 18 to 89 years old.
- Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record).
- Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride \> 90 mmol/L.
Exclusion
- Subjects under the age of 18 or over the age of 89.
- Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons.
- Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period.
- Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04056702
Start Date
September 5 2019
End Date
July 1 2022
Last Update
March 11 2021
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206