Sinonasal Therapies and Histologic Correlations for Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
Indiana University
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)
Description
Cystic fibrosis (CF) is a widely known genetic disorder causing patients significant sinopulmonary disease. (1) The advent of highly effective modulator therapy (HEMT) has led to tremendous improvements in manifestations of disease in the lungs, sinuses, along with other organ systems, raising the question of whether and how to de-escalate other treatments for the airways. Specifically for CF, no protocols exist for the de-escalation of the most common sinonasal therapies: high-volume nasal saline irrigations, topical nasal steroids, and topical nasal antibiotics. Establishing such protocols w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 highly effective modulator therapy * 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 wi…
Interventions
- OtherSTOP NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
PATIENT WILL STOP USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
- DrugCONTINUE NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
PATIENT WILL CONTINUE USING NASAL SALINE IRRIGATION WITH OR WITHOUT STEROID
Location
- Indiana University HealthIndianapolis, Indiana