Sinonasal Therapies and Histologic Correlations for Patients with Cystic Fibrosis in the Era of Highly Effective Modulator therapy
Investigating Sinonasal Therapy De-escalation in Cystic Fibrosis Patients on Investigational Therapy
Elisa Illing
Primary Investigator
Brief description of study
Establish a protocol for de-escalation of sinonasal therapies for patients on cystic fibrosis transmembrane regulator (CFTR) modulator therapies in a multidisciplinary fashion that includes a Rhinology perspective. Test the hypothesis that patients with cystic fibrosis on CFTR modulator therapy with refractory sinus disease exhibit continued tissue neutrophilic inflammation.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified and approached in clinic during their regularly schedule appointments.
Detailed description of study
- Evaluate de-escalation of Sinonasal therapies for patients on CFTR modulator therapies in a multidisciplinary fashion that includes a Rhinology perspective
- Prospectively follow adult cystic fibrosis patients with chronic rhinosinusitis with or without history of sinus surgery currently using CFTR modulator therapy via diagnostic methods (nasal endoscopy, FEV1, BMI), health care utilization (antibiotics, steroids, hospital admissions, doctor visits), patient reported outcome measures (PROMS) (SNOT-22, Cystic Fibrosis Questionnaire- Revised (CFQ-R), Patient Health Questionnaire-9 (PHQ-9)) and randomly assign them to continue or stop topical medicated nasal irrigations.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cystic Fibrosis, CF, Chronic rhinosinusitis
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
- Age 18 or older
- Cystic Fibrosis diagnosis on HEMT
- History of chronic rhinosinusitis
- Using topical nasal irrigations +/- additives (steroids, antibiotics)
Exclusion Criteria
- Below age of 18 years old
- Cystic Fibrosis patient NOT on HEMT
- 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
This study investigates the effects of reducing sinonasal therapies in patients with cystic fibrosis who are on cystic fibrosis transmembrane regulator (CFTR) modulator therapy. Cystic fibrosis is a genetic disorder that affects the lungs and other organs, characterized by thick, sticky mucus that can clog airways and lead to respiratory issues. The study aims to understand if patients with persistent sinus disease continue to show signs of tissue inflammation despite being on these therapies.
Participants in the study will undergo various diagnostic methods such as nasal endoscopy, lung function tests (FEV1), and body mass index (BMI) assessments. They will also be monitored for healthcare utilization, including antibiotic and steroid use, hospital admissions, and doctor visits. Additionally, patient-reported outcomes will be collected through questionnaires like SNOT-22, Cystic Fibrosis Questionnaire-Revised (CFQ-R), and Patient Health Questionnaire-9 (PHQ-9). Participants will be randomly assigned to either continue or stop using topical medicated nasal irrigations.
- Who can participate: Adults 18 or older with cystic fibrosis on highly effective modulator therapy (HEMT) and chronic rhinosinusitis, currently using topical nasal irrigations with or without additives like steroids or antibiotics, are eligible.
- Study details: Participants will be randomly assigned to either continue or stop using topical medicated nasal irrigations. They will undergo diagnostic tests and complete questionnaires to evaluate their sinonasal health and overall well-being. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, may be used for comparison.
