Mometasone vs Budesonide in CRS With Polyposis

NCT ID: NCT03323866

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-08-01

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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Mometasone nasal spray

Intervention Type DRUG

Mometasone 50 mcg/spray 2 sprays twice daily

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

Group Type EXPERIMENTAL

Budesonide 0.5 MG/ML

Intervention Type DRUG

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

Interventions

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Budesonide 0.5 MG/ML

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

Intervention Type DRUG

Mometasone nasal spray

Mometasone 50 mcg/spray 2 sprays twice daily

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Marie Bussières

Otolaryngologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Université de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2017-1569

Identifier Type: -

Identifier Source: org_study_id

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