Sinonasal Therapies in Cystic Fibrosis Patients on Highly Effective Modulator Therapy
This study is looking at whether people with Cystic Fibrosis (CF) who are taking highly effective modulator therapy (HEMT) can safely stop using certain nose treatments. These treatments include nasal saline irrigation (with or without steroids). Researchers want to see if stopping these treatments changes your nose health, measured by your Lund Kennedy Score, lung function, and body mass index (BMI) over 12 weeks. You can join if you are 18 or older, have CF and are on HEMT, have a history of chronic rhinosinusitis (a long-term sinus condition), and currently use topical nasal irrigations. The study aims to understand if these nose treatments are still needed once you are on HEMT.
- Study design
- This is an interventional study with a planned enrollment of 64 participants. It compares continuing nasal saline irrigation with or without steroid to stopping it.
- What's involved
- Participants will either stop or continue using their nasal saline irrigation with or without steroid. Measurements for Lund Kennedy Score, pulmonary function, and BMI will be taken at the beginning and after 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 weeks, with measurements taken at baseline and at the end of this period.
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Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Elisa Illing, MD · PRINCIPAL_INVESTIGATOR · Indiana University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Lund Kennedy ScoreBaseline, 12 weeks
Nasal Endoscopy will be performed in the clinic to evaluate the sinonasal cavities using the Lund Kennedy scoring system. The Lund-Kennedy endoscopic score grades the severity of chronic rhinosinusitis (CRS) based on findings from five areas: polyps, discharge, edema, scarring, and crusting, with each graded on a scale of 0 to 2 for each nostril, resulting in a total possible score of 20. A higher score indicates more severe disease.
- Change in Pulmonary Function TestingBaseline, 12 weeks
PULMONARY FUNCTION TESTING WILL BE PERFORMED WITH THE FEV1/FVC , CALCULATED. A lower score means poorer lung function.
- Change in Body Mass Index (BMI)Baseline, 12 weeks
BMI will be calculated as weight (kg) / height (m)2
- Change in Health Care UtilizationBaseline, 12 weeks
Health Care Utilization will be measured though a grouped analysis for additional doctor visits, hospital admissions, and use of antibiotics and oral steroids.
- Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) ScoreBaseline, 12 weeks
The SNOT-22 measures nasal symptoms and social/emotional consequences of rhinosinusitis, rated on a scale of 0 (no problem) to 5 (problem is as bad as it can be). Scores may range from 0 to 110, with higher scores indicating worse sinus symptoms
- Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) ScoreBaseline, 12 weeks
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents and adults with cystic fibrosis (CF). It is a profile measure of HRQOL with several different domains. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) application calculates the score derived from the CFQ-R, on a 0-100 scale with higher scores indicating better HRQoL.
- Change in Patient Health Questionnaire-9 (PHQ-9) ScoreBaseline, 12 weeks
The PHQ-9 measures severity of depression. Potential scores may range from 0 - 27 with higher scores indicating more severe depression.