Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The overall goal of this proposed research project is to optimize topical delivery of MF to the paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure nasal saline irrigation. The investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the effectiveness of MF nasal irrigation compared to MF nasal spray.

Official Title
-----------------
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

Conditions
-----------------
Chronic Rhinosinusitis (Diagnosis), Allergic Rhinosinusitis, Chronic Eosinophilic Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: Mometasone Furoate Nasal Irrigation
* Drug: Mometasone Nasal Spray


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone Furoate Nasal Irrigation<br>The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray. | Drug: Mometasone Furoate Nasal Irrigation<br>* Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.<br>|
| Active Comparator: Mometasone Nasal Spray<br>The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray. | Drug: Mometasone Nasal Spray<br>* Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.<br>* Other names: Nasonex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-Nasal Outcome Test Scores (SNOT-22) | The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how bad their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks) | Change from Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Score <3 on the Clinical Global Impression Scale | CGI asks subjects to rate their overall response to treatment using a 7-point Likert scale with anchors of 1=very much improved, 4=no change, and 7=very much worse. | Week 8 | 
| Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System | A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system. The The Lund Kennedy System grades the pathologic state of the nasal cavity based on the presence of polyps, nasal discharge, and mucosal edema. Polyps graded from 0 to 2 (0=absent, 1=limited to middle meatus, 2=extending to nasal cavity) Discharge graded from 0 to 2 (0=absent, 1=thin/clear, 2=thick) Edema graded from 0 to 2 (0=absent, 1=mild/moderate, 2=polypoid degeneration). Scores are added for each side of the nose with a minimum score of 0 and maximum score of 12 with higher scores indicating more severe sinonasal inflammation. | Change from Baseline to Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mometasone irrigation, mometasone spray, chronic rhinosinusitis