Status:
RECRUITING
Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
Lead Sponsor:
Indiana University
Collaborating Sponsors:
American Rhinologic Society
Conditions:
Cystic Fibrosis (CF)
Chronic Rhinosinusitis (CRS)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The investigators are doing this study to discover if it is appropriate for people with Cystic Fibrosis (CF) on highly effective modulator therapy (HEMT) to stop using certain standard Sino nasal ther...
Detailed Description
Cystic fibrosis (CF) is a widely known genetic disorder causing patients significant sinopulmonary disease. (1) The advent of highly effective modulator therapy (HEMT) has led to tremendous improvemen...
Eligibility Criteria
Inclusion
- Age 18 or older
- Cystic Fibrosis diagnosis on HEMT
- History of chronic rhinosinusitis
- Using topical nasal irrigations +/- additives (steroids, antibiotics)
Exclusion
- Below age of 18 years old
- Cystic Fibrosis patient NOT on highly effective modulator therapy
- Pregnant patients
- Not currently using topical nasal irrigations +/- additives (steroids, antibiotics)
- History of sinonasal or nasopharyngeal tumors
- Active sinonasal infection or pulmonary infection
- Admission to hospital for pulmonary exacerbation within last 3 months
- Oral antibiotics within last one month for upper respiratory or lower respiratory infection
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06996951
Start Date
July 2 2025
End Date
July 1 2026
Last Update
December 16 2025
Active Locations (1)
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1
Indiana University Health
Indianapolis, Indiana, United States, 46202