Mometasone vs Budesonide in CRS With Polyposis

Université de Sherbrooke

Status and phase: Terminated; Phase 3

Conditions: Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Treatments: Drug: Budesonide 0.5 MG/ML; Drug: Mometasone nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03323866

2017-1569

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Mometasone nasal spray

Active Comparator group

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

Treatment:

Drug: Mometasone nasal spray

Budesonide irrigation

Experimental group

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

Treatment:

Drug: Budesonide 0.5 MG/ML