Mometasone vs Budesonide in CRS With Polyposis

Phase 3

Terminated

• Conditions: Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
• Interventions: Drug: Mometasone nasal spray; Drug: Budesonide 0.5 MG/ML

• Registration Number: NCT03323866
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Primary Completion: 2022-05-01
• Study Completion: 2022-08-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mometasone nasal spray	Mometasone nasal spray	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
Budesonide irrigation	Budesonide 0.5 MG/ML	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

Primary Outcome Measures

Name	Time	Method
Disease specific quality of life questionnaire	3 months after beginning of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Endoscopic evaluation of the nasal cavities	3 months after beginning of treatment	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).

Trial Locations

Locations (1)

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada