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

NCT06996951 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 26204
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Cystic Fibrosis (CF); Chronic Rhinosinusitis (CRS)

Outcome Measures

Primary Outcomes (7)

• Change in Lund Kennedy Score

  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.

  Baseline, 12 weeks

• Change in Pulmonary Function Testing

  PULMONARY FUNCTION TESTING WILL BE PERFORMED WITH THE FEV1/FVC , CALCULATED. A lower score means poorer lung function.

  Baseline, 12 weeks

• Change in Body Mass Index (BMI)

  BMI will be calculated as weight (kg) / height (m)2

  Baseline, 12 weeks

• Change in Health Care Utilization

  Health Care Utilization will be measured though a grouped analysis for additional doctor visits, hospital admissions, and use of antibiotics and oral steroids.

  Baseline, 12 weeks

• Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) Score

  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

  Baseline, 12 weeks

• Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score

  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.

  Baseline, 12 weeks

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  The PHQ-9 measures severity of depression. Potential scores may range from 0 - 27 with higher scores indicating more severe depression.

  Baseline, 12 weeks

Secondary Outcomes (1)

• Change in nasal mucous biomarkers.

  Baseline, 12 weeks

Study Arms (2)

CONTINUE TOPICAL STEROID NASAL IRRIGATION

ACTIVE COMPARATOR

PARTICIPANTS WILL CONTINUE THEIR NASAL TREATMENT WHICH WAS ALREADY PRESCRIBED BY THEIR PHYSICIAN

Drug: CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

STOP TOPICAL NASAL TREATMENT

EXPERIMENTAL

PARTICIPANTS IN THIS ARM WILL BE ASKED TO STOP THEIR NASAL TREATMENT

Other: STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Interventions

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID OTHER

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

STOP TOPICAL NASAL TREATMENT

CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID DRUG

PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

CONTINUE TOPICAL STEROID NASAL IRRIGATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead
• American Rhinologic Society: collaborator

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Elisa Illing, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Illing, MD

CONTACT

317-944-6467; eilling@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)