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

Recruiting now · Phase 3

Conditions studied: Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS)

In brief

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)

Key facts

Study ID

NCT06996951

Run by

Indiana University

People needed

64

Starts

2025-07-02

Expected to finish

2026-07-01

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Cystic Fibrosis diagnosis on HEMT
• History of chronic rhinosinusitis
• Using topical nasal irrigations +/- additives (steroids, antibiotics)

You may not qualify if…

• 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

Where it is running

• Indiana University Health — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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