Mometasone vs Budesonide in CRS With Polyposis

Sponsor

Université de Sherbrooke (Other)

Overall Status

Recruiting

CT.gov ID

NCT03323866

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis	Drug: Budesonide 0.5 MG/ML Drug: Mometasone nasal spray	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposisRandomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Mometasone nasal spray Mometasone 50 mcg/spray 2 sprays twice daily
Experimental: Budesonide irrigation 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 2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Mometasone nasal spray

Mometasone 50 mcg/spray 2 sprays twice daily

Experimental: Budesonide irrigation

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

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

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Université de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

Université de Sherbrooke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marie Bussières, Otolaryngologist, Université de Sherbrooke

ClinicalTrials.gov Identifier:

NCT03323866

Other Study ID Numbers:

2017-1569

First Posted:

Oct 27, 2017

Last Update Posted:

Nov 4, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Nasal Polyps

Mometasone Furoate

Budesonide

Study Results

No Results Posted as of Nov 4, 2020