Phase 4
N=53
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Chronic Rhinosinusitis (Diagnosis) · Allergic Rhinosinusitis · Chronic Eosinophilic Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT03705793 ↗Enrolled (actual)
53
Serious AEs
1.9%
Results posted
Dec 2020
Primary outcome: Primary: Change in Sino-Nasal Outcome Test Scores (SNOT-22) — 23.18; 17.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mometasone Furoate Nasal Irrigation (Drug); Mometasone Nasal Spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sino-Nasal Outcome Test Scores (SNOT-22) |
23.18; 17.7 | — |
| SECONDARY Number of Participants Who Score <3 on the Clinical Global Impression Scale |
22; 20 | — |
| SECONDARY Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System |
2.2; 2.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03705793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.