Impact of Triple Combination CFTR Therapy on Sinus Disease.

  • STATUS
    Recruiting
  • End date
    Jul 19, 2022
  • participants needed
    31
  • sponsor
    Jennifer Taylor-Cousar
Updated on 19 March 2021

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.

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 CT scan and complete questionnaires related to signs and symptoms of sinus disease.

Details
Condition Pulmonary Disease, Lung Disease, Cystic Fibrosis, Cystic Fibrosis, Pancreatic disorder, Pancreatic Disorders, Pancreatic Disorders, Lung Disease
Treatment Elexacaftor-tezacaftor-ivacaftor exposure
Clinical Study IdentifierNCT04056702
SponsorJennifer Taylor-Cousar
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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