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

NCT06996951 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-12-16

No results posted yet for this study

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)

Interventions

OTHER

STOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

DRUG

CONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID

Sponsors & Collaborators

  • American Rhinologic Society

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Elisa Illing, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06996951 on ClinicalTrials.gov