Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study (Betadine)
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|ClinicalTrials.gov Identifier: NCT04097613|
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Povidone Iodine solution is a nasal antiseptic. Its application has been shown to be clinically safe, tolerable and effective against bacteria and fungi associated with chronic rhinosinusitis.
This study will evaluate the effectiveness of Povidone Iodine in this hard-to-treat patient group. Furthermore, the study will also further evaluate any side effects that may occur with the use of Povidone Iodine.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis (Diagnosis)||Drug: Povidone-Iodine Drug: Budesonide||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cohort study|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy of Topical Povidone - Iodine Rinses in the Management of Biofilm-associated Chronic Rhinosinusitis|
|Actual Study Start Date :||July 28, 2017|
|Actual Primary Completion Date :||April 1, 2019|
|Actual Study Completion Date :||August 31, 2019|
Experimental: Betadine Treatment
Study subjects will use betadine saline sinus rinse for period of 6 weeks.
Povidone Iodine solution 5% (0.5% available iodine) by 3MTM has been specially formulated as a nasal antiseptic. They have shown topical application to be clinically safe, tolerable and to be rapidly bacteriocidal against aerobic gram positive and gram- negative bacteria including methicillin resistant Staphylococcus aureus, methicillin resistant Staphylococcus epidermidis, vancomycin resistant Enterococcus faecium and Enterococcus faecalis (VRE) and yeast (3M study 05-011100,05-011017, 05-011322).
Other Name: Betadine
Budesonide is is provided in nebules (1mg/2cc). Patients will place two nebules of budesonide into the 250mls of saline.
Other Name: Pulmicort
- MLK endoscopic grading [ Time Frame: 6 weeks ]differences in Modified Lund-Kennedy (MLK) endoscopic score after 6 weeks of using Povidone-iodine (PVP-I) sinus rinses.
- Quality of Life determined by SNOT-22 Questionnaire [ Time Frame: 6 weeks ]disease specific quality of life questionnaire score (SNOT-22) in recalcitrant/recurrent CRS patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097613
|Canada, British Columbia|
|St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||Amin Javer, M.D.||University of British Columbia|