Back to resultsMometasone vs Budesonide in CRS With Polyposis
Primary Purpose
Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Budesonide 0.5 MG/ML
Mometasone nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
Eligibility Criteria
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
Sites / Locations
- Université de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mometasone nasal spray
Budesonide irrigation
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT03323866
First Posted
October 24, 2017
Last Updated
September 16, 2022
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT03323866
Brief Title
Mometasone vs Budesonide in CRS With Polyposis
Official Title
Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruitment
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone nasal spray
Arm Type
Active Comparator
Arm Description
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
Arm Title
Budesonide irrigation
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Budesonide 0.5 MG/ML
Intervention Description
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
Intervention Type
Drug
Intervention Name(s)
Mometasone nasal spray
Intervention Description
Mometasone 50 mcg/spray 2 sprays twice daily
Primary Outcome Measure Information:
Title
Disease specific quality of life questionnaire
Description
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 Outcome Measure Information:
Title
Endoscopic evaluation of the nasal cavities
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Mometasone vs Budesonide in CRS With Polyposis
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