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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 16, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Cystic Fibrosis (CF)Chronic Rhinosinusitis (CRS)
Interventions
DIAGNOSTIC_TEST

:PULMONARY FUNCTION TEST

PATIENT WILL HAVE PULMONARY FUNCTION TESTING PERFORMED, MEASURING FEV1/FVC.

DIAGNOSTIC_TEST

NASAL ENDOSCOPY

PATIENT WILL HAVE NASAL ENDOSCOPY TO RECORD LUND KENNEDY ENDOSCOPIC SCORE

DIAGNOSTIC_TEST

LEUKOSORB FILTER PAPER APPLICATION TO NASAL CAVITY

LEUKOSORB FILTER PAPER STRIP WILL BE APPLIED INSIDE THE NOSTRIL TO SAMPLE NASAL MUCOUS TO OBTAIN IMMUNOGLOBULIN LEVELS TO MONITOR INFLAMMATION WITHIN THE NASAL MUCOUS

BEHAVIORAL

SINONASAL OUTCOME TEST 22 QUESTIONNAIRE

PATIENT WILL COMPLETE THE SINONASAL OUTCOME TEST 22 QUESTIONNAIRE TO EVALUATE FOR SINONASAL SYMPTOMS DURING THE STUDY

BEHAVIORAL

CYSTIC FIBROSIS QUESTIONNAIRE-REVISED

PATIENT WILL COMPLETE THE CYSTIC FIBROSIS QUESTIONNAIRE-REVISED TO EVALUATE FOR CYSTIC FIBROSIS RELATED SYMPTOMS DURING THE STUDY

BEHAVIORAL

PATIENT HEALTH QUESTIONNAIRE-9

PATIENT WILL COMPLETE THE PATIENT HEALTH QUESTIONNAIRE-9 TO EVALUATE FOR QUALITY OF LIFE DURING THE STUDY

DRUG

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Trial Locations (1)

46202

Indiana University Health, Indianapolis

All Listed Sponsors
collaborator

American Rhinologic Society

OTHER

lead

Indiana University

OTHER