Mometasone vs Budesonide in CRS With Polyposis

Study Overview
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Brief Summary
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The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.

Official Title
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Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis

Conditions
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Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Intervention / Treatment
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* Drug: Budesonide 0.5 MG/ML
* Drug: Mometasone nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic rhinosinusitis with nasal polyps Absence of active infection at start of study Exclusion Criteria: Diagnosis of chronic rhinosinusitis without nasal polyps Diagnosis of recurrent acute bacterial rhinosinusitis Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries) Cystic fibrosis or ciliary dyskinesia Allergy to corticosteroids Pregnant or lactating women Contra-indication to intranasal steroids

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mometasone nasal spray<br>Mometasone nasal spray 50 mcg/dose, 2 sprays/nostril twice daily x 3 months Patients will also be taking Sinus Rinse once daily throughout the study period | Drug: Mometasone nasal spray<br>* Mometasone 50 mcg/spray 2 sprays twice daily<br>|
| Experimental: Budesonide irrigation<br>2 cc budesonide nebule (0,5 mg/cc) incorporated to 240 of saline water (Sinus Rinse) to be taken on a daily basis x 3 months | Drug: Budesonide 0.5 MG/ML<br>* 2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific quality of life questionnaire | SinoNasal Outcome Test - 22 This is a symptom score ranging from 0 to 110 points, 0 representing the absence of nasal symptoms and 110 being the most severe symptoms. | 3 months after beginning of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic evaluation of the nasal cavities | Lund Kennedy Endoscopic Score This is a score evaluating the healing of sinonasal cavities from 0 point (normal and healthy looking cavity) to 20 points (the most diseased cavity). | 3 months after beginning of treatment |