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Corticosteroid
Budesonide irrigation for Sinusitis
Phase 3
Waitlist Available
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after beginning of treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether a nasal spray or a nose irrigation is more effective for people with chronic sinus problems who have not had surgery.
Eligible Conditions
- Sinusitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after beginning of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after beginning of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Disease specific quality of life questionnaire
Secondary study objectives
Endoscopic evaluation of the nasal cavities
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Budesonide irrigationExperimental Treatment1 Intervention
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
Group II: Mometasone nasal sprayActive Control1 Intervention
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
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Who is running the clinical trial?
Université de SherbrookeLead Sponsor
304 Previous Clinical Trials
76,693 Total Patients Enrolled
1 Trials studying Sinusitis
16 Patients Enrolled for Sinusitis
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