Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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 therapies such as high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. They are also going to study the fluid inside the nose to see if there are changes when stopping these therapies. Right now, they are not sure if it is suggested to stop these treatments when patients begin highly effective modulator therapy (HEMT)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• Cystic Fibrosis diagnosis on HEMT

• History of chronic rhinosinusitis

• Using topical nasal irrigations +/- additives (steroids, antibiotics)

Locations
United States
Indiana
Indiana University Health
RECRUITING
Indianapolis
Contact Information
Primary
Elisa Illing, MD
eilling@iu.edu
317-944-6467
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2026-07
Participants
Target number of participants: 64
Treatments
Active_comparator: CONTINUE TOPICAL STEROID NASAL IRRIGATION
PARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN
Experimental: STOP TOPICAL NASAL TREATMENT
PARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT
Related Therapeutic Areas
Sponsors
Collaborators: American Rhinologic Society
Leads: Indiana University

This content was sourced from clinicaltrials.gov