Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Chronic Rhinosinusitis Clinical Trial

Official title:

Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02720653
• Other study ID #: DC005805-11
• Status: Active, not recruiting
• Start date: July 1, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 418
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adult ( > 18 years of age)

• A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology

• Provide written informed consent and authorization.

• Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.

• Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.

• Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider

• Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (>14-days) of culture-directed or broad spectrum antibiotic therapy.

Exclusion Criteria:

• Children (< 18 years of age)

• Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.

• Non-English speaking / English translation services required

• Unwilling or unable to provide informed, written consent.

• Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS

• Patients who have not undergone previous prescribed medical therapy as described in Inclusion Criteria.

• Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Olfactory Dysfunction
• Sinusitis

Intervention

Procedure:
• Endoscopic sinus surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sniffin' Stick olfactory testing	Improvement in olfactory function	6 months
Secondary	22-Item Sinonasal Outcome Test	Improvement in disease specific quality of life	6 months
Secondary	Questionnaire for Olfactory Dysfunction, QOD-NS	Improvement in olfactory specific quality of life	6 months