Mometasone vs Budesonide in CRS With Polyposis

Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03323866
• Other study ID #: 2017-1569
• Status: Terminated
• Phase: Phase 3
• Start date: May 1, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
• Colorectal Neoplasms
• Nasal Polyps
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Budesonide 0.5 MG/ML
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
• Mometasone nasal spray
Mometasone 50 mcg/spray 2 sprays twice daily

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	3 months after beginning of treatment