Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis (NCT03705793) | Clinical Trial Compass
CompletedPhase 4
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
United States53 participantsStarted 2019-01-01
Plain-language summary
Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.
Who can participate
Age range
18 Years – 70 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:
12-weeks or longer of two or more of the following signs and symptom consistent with CRS:
* mucopurulent drainage(anterior, posterior, or both)
* nasal obstruction (congestion)
* facial pain-pressure-fullness
* and decreased sense of smell
AND inflammation documented by one or more of the following findings:
* purulent mucus or edema in the middle meatus or ethmoid region
* radiographic imaging showing inflammation of the paranasal sinuses.
Exclusion Criteria:
* inability to speak or understand English
* nasal polyps
* history of nasal or sinus surgery
* comorbid mucociliary conditions
* dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
* history of oral or systematic antibiotic use in the past 2 weeks
* history of allergy to MF or other topical steroids
* pregnant or breastfeeding
* participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.
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 Sino-Nasal Outcome Test Scores (SNOT-22)