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Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

NCT04097613 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-09-20

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Interventions

DRUG

Povidone-Iodine

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).

DRUG

Budesonide

Budesonide is is provided in nebules (1mg/2cc). Patients will place two nebules of budesonide into the 250mls of saline.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin Javer, M.D. · University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-28
Primary Completion
2019-04-01
Completion
2019-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097613 on ClinicalTrials.gov