Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
Conditions
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.
Interventions
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
Mometasone 50 mcg/spray 2 sprays twice daily
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Canada
Outcome results
None listed