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.
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.
Study Type
OBSERVATIONAL
Enrollment
31
Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study.
National Jewish Health
Denver, Colorado, United States
RECRUITINGChange in Sinus CT opacification.
Calculated from an automated quantification of the size of sinuses.
Time frame: Change in Sinus CT opacification between the initial and 6 month visits.
Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score.
Validated, disease-specific measure of sinus symptoms. Contains 22 questions that are all scored from 0 to 5, when summed a total score ranges form 0 to 110. Higher scores represent worse sinus symptoms.
Time frame: Change in SNOT-22 score between the initial and 6 month visits.
Change in Questionnaire for Olfactory Disorders (QOD) score
Validated, disease-specific measure of olfaction, i.e. the ability to smell. Contains 19 questions that are scored form 0 to 3, when summed a total score can range form 0 to 57. Higher scores indicate greater impact on a subjects sense of smell.
Time frame: Change in QOD score between the initial and 6 month visits.
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