Betadine Rinses for Chronic Rhinosinusitis Prospective Cohort Study

NCT04097613 | Completed Early Phase 1

• 1 other identifier: H17-01373
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Betadine; Povidone Iodine; CRS; Biofilm; Recalcitrant

Outcome Measures

Primary Outcomes (1)

• MLK endoscopic grading

  differences in Modified Lund-Kennedy (MLK) endoscopic score after 6 weeks of using Povidone-iodine (PVP-I) sinus rinses.

  6 weeks

Secondary Outcomes (1)

• Quality of Life determined by SNOT-22 Questionnaire

  6 weeks

Study Arms (1)

Betadine Treatment

EXPERIMENTAL

Study subjects will use betadine saline sinus rinse for period of 6 weeks.

Drug: Povidone-Iodine; Drug: Budesonide

Interventions

Povidone-Iodine DRUG

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).

Also known as: Betadine

Betadine Treatment

Budesonide DRUG

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

Also known as: Pulmicort

Betadine Treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

MeSH Terms

Conditions

Disease

Interventions

Povidone-Iodine; Budesonide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Amin Javer, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Cohort study

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: September 20, 2019
• Study Start: July 28, 2017
• Primary Completion: April 1, 2019
• Study Completion: August 31, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)