Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Chronic Rhinosinusitis Clinical Trial

Official title:

Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332136
• Other study ID #: 2R01DC005805
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: March 28, 2016
• Start date: April 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult (>= 18 years)

• Chronic rhinosinusitis as defined by the 2007 multi-disciplinary adult sinusitis guidelines

• Able to complete all surveys/questionnaires in English

• Persistent symptoms following initial medical management

• Received at least 1 course of broad spectrum antibiotics or culture directed antibiotics for at least a total of 14 days

• Received at least a 3 week trial of topical steroid sprays OR at least a 5 day trial of systemic corticosteroid therapy.

• Counseled for subsequent treatment options including either medical management or endoscopic sinus surgery

Exclusion Criteria:

• Children (<18 years)

• Unable to complete all surveys/questionnaires at baseline

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific quality of life		18 months post-treatment	No
Secondary	General health-related quality-of-life		18 months post-treatment	No
Secondary	Olfaction		18 months post-treatment	No