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

StatusRecruiting
PhasePhase 3
Started2025-07-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 16, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-10
Study Status, Study Description, Arms and Interventions, Outcome Measures v3
Start date2025-06-16→2025-07-02
Interventions:PULMONARY FUNCTION TEST (Diagnostic Test), CYSTIC FIBROSIS QUESTIONNAIRE-REVISED (Behavioral), LEUKOSORB FILTER PAPER APPLICATION TO NASAL…→CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID (Drug), STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID (Other)
Secondary endpoints1 entry, revised
LeukosorbChange test strips ofin nasal mucous biomarkers.
Primary endpoints4 to 7 entries
Change in Body Mass Index (BMI) Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score Change in Health Care Utilization NasalChange endoscopyin Lund Kennedy Score PULMONARYChange FUNCTIONin TESTPatient Health Questionnaire-9 (PHQ-9) Score SINONASALChange OUTCOMEin TESTPulmonary Function Testing Change in Sinonasal Outcome Test 22 QUESTIONNAIREQuestionnaire (SNOT-22) Score
Study description-5 characters
[...] ed to continue or stop topical medicated nasal irrigations. The investigatorsParticipants will continue the 1-2 times per day they currently perform [...]
2025-10-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-06-10
Study Status, Oversight, Study Design, Contacts/Locations v1
PhaseNot applicable→Phase 3
Start date2025-05→2025-06-16
Study sites0→1
2025-05-21
Original filing
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)
Trial Details
NCT Number NCT06996951
Lead Sponsor Indiana University
Collaborators: American Rhinologic Society
Conditions Cystic Fibrosis (CF), Chronic Rhinosinusitis (CRS)
Enrollment 64 participants
Start Date 2025-07-02
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-12-16