A Phase 3 interventional study of Budesonide 0.5 MG/ML and Mometasone nasal spray in Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis, sponsored by Université de Sherbrooke. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Université de Sherbrooke · Phase 3, Interventional, and Treatment
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.
Université de Sherbrooke is the lead sponsor of 295 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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
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
Drug page: Budesonide
2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
Mometasone 50 mcg/spray 2 sprays twice daily
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.
Time frame: 3 months after beginning of treatment
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).
Time frame: 3 months after beginning of treatment
This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Budesonide