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Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study (Betadine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097613
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Povidone-Iodine Drug: Budesonide Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Betadine Treatment
Study subjects will use betadine saline sinus rinse for period of 6 weeks.
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).
Other Name: Betadine

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 19 years or older
  • Diagnosed with CRS with biofilm recalcitrant/recurrent after a trial of at least 3 months of a combination of well executed sinus surgery, regular irrigation with topical steroids or mucosal atomization device and surfactants24
  • Continued symptoms colored nasal discharge, post nasal drip, nasal congestion, decreased sense of smell, mucosal edema or polyps despite the above stated intervention

Exclusion Criteria

  • Patients with sinonasal tumors.
  • Patients with autoimmune diseases affecting the upper airway

    o eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc.

  • Immuno-compromised patients, and patients with impairment in mucociliary function

    o (e.g., cystic fibrosis, Kartagener syndrome)

  • Hypersensitivity to iodine
  • History of thyroid disorders including thyroid cancer, hyperthyroidism and hypothyroidism
  • Use of medications for thyroid disorders including thyroxine and carbimazole
  • Pregnancy
  • Patients unable to speak English.

Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
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Principal Investigator: Amin Javer, M.D. University of British Columbia

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Responsible Party: Amin Javer, Clinical Professor, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT04097613     History of Changes
Other Study ID Numbers: H17-01373
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will publish final outcomes as scientific paper.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Betadine
Povidone Iodine
CRS
Biofilm
Recalcitrant
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Iodine
Cadexomer iodine
Povidone-Iodine
Budesonide
Povidone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Plasma Substitutes
Blood Substitutes