Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Hi… (NCT06996951) | Clinical Trial Compass
RecruitingPhase 3
Sinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy
United States64 participantsStarted 2025-07-02
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 within last one month for upper respiratory or lower respiratory infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Lund Kennedy Score
Timeframe: Baseline, 12 weeks
2
Change in Pulmonary Function Testing
Timeframe: Baseline, 12 weeks
3
Change in Body Mass Index (BMI)
Timeframe: Baseline, 12 weeks
4
Change in Health Care Utilization
Timeframe: Baseline, 12 weeks
5
Change in Sinonasal Outcome Test 22 Questionnaire (SNOT-22) Score
Timeframe: Baseline, 12 weeks
6
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score
Timeframe: Baseline, 12 weeks
7
Change in Patient Health Questionnaire-9 (PHQ-9) Score