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

What this Trial Is About

Researchers are investigating whether adults with Cystic Fibrosis (CF) who are on highly effective modulator therapy (HEMT) can safely stop using common sinonasal treatments like nasal saline irrigations, topical nasal steroids, and antibiotics. This phase 3 study aims to understand changes in nasal inflammation and clinical outcomes when these therapies are stopped, as current guidelines for de-escalation do not exist. The study focuses on patients with chronic rhinosinusitis and explores how stopping these treatments affects their sinonasal and lung health. Participants will be randomly assigned to either continue or stop their prescribed topical nasal treatments, including saline irrigations with or without steroids, for a 12-week period. Researchers will collect nasal fluid samples every 4 weeks to analyze inflammation markers, using a special nasal strip method. The study compares clinical measures such as lung function, body mass index, symptom scores, and healthcare use at the start and end of the trial to assess the effects of continuing versus stopping nasal therapies. During the study, participants will undergo standard evaluations like nasal endoscopy, lung function tests, and complete questionnaires on symptoms and quality of life at both rhinology and pulmonary visits. Researchers will monitor healthcare visits, antibiotic use, and hospital admissions as part of routine care. The total participation lasts 12 weeks, with nasal fluid sampling and clinical assessments occurring at baseline and every 4 weeks to track changes in sinonasal health and patient-reported outcomes.

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