Mometasone vs Budesonide in CRS With Polyposis

Phase 3TerminatedNCT03323866

Université de Sherbrooke36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Interventions

Budesonide 0.5 MG/MLDRUG

2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily

Mometasone nasal sprayDRUG

Mometasone 50 mcg/spray 2 sprays twice daily

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: 3 months after beginning of treatment

Secondary Outcomes

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).

Time frame: 3 months after beginning of treatment

Data from ClinicalTrials.gov

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