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Difficulty with recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide 0.5 MG/ML | Drug | 2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
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| Mometasone nasal spray | Drug | Mometasone 50 mcg/spray 2 sprays twice daily |
|
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |