Mometasone vs Budesonide in CRS With Polyposis

NCT03323866 | Terminated Phase 3

• 1 other identifier: 2017-1569
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after beginning of treatment

Secondary Outcomes (1)

• Endoscopic evaluation of the nasal cavities

  3 months after beginning of treatment

Study Arms (2)

Mometasone nasal spray

ACTIVE COMPARATOR

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

Budesonide irrigation

EXPERIMENTAL

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

Interventions

Budesonide 0.5 MG/ML DRUG

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

Budesonide irrigation

Mometasone nasal spray DRUG

Mometasone 50 mcg/spray 2 sprays twice daily

Mometasone nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic rhinosinusitis with nasal polyps
• Absence of active infection at start of study

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Disease; Nasal Polyps

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otolaryngologist

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

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

CA (1)