Unified Airway Model

• Conditions: Chronic Rhinosinusitis (Diagnosis); Asthma

• Registration Number: NCT03937427
• Lead Sponsor: University of British Columbia

Brief Summary

Chronic rhinosinusitis (CRS) impacts approximately 5% of Canadians. CRS patients suffer from a combination of symptoms that include facial pain, nasal obstruction, hyposmia and mucopurulence discharge. Asthma may additionally worsen quality of life and many patients suffer from both conditions. The unified airway model illustrates a link between both conditions as tissue from the middle ear to the sinus cavity to the lungs function as one unit. Despite evidence for the unified airway model in the setting of CRS and asthma, there are no studies to our knowledge that have evaluated the microbiome (the resident microbes and their genetic expressions that affect disease) of the upper and lower airways in this patient population. Determining the microbiome of the upper and lower airways in patients suffering from CRS and asthma will further support the unified airway model but more importantly, will help contribute to understanding the pathophysiology of this inflammatory process and may help guide future management.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-16
• Status Verified: 2019-05
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Last Update Submitted: 2019-05-01
• Study First Posted: 2019-05-03
• Last Update Posted: 2019-05-03
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 19 years or older
• Able to speak and understand English
• Diagnosed with chronic rhinosinusitis with or without asthma and COPD or with a sinonasal tumor
• Undergoing sinus surgery in St Paul's Hospital

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Exclusion Criteria

• Oral antibiotics in the past month prior to surgery;
• Immunocompromised;
• Prior lung transplants;
• Known sinonasal or bronchial tumors, current or previous;
• Smoking;
• Known bleeding disorders:
• Deemed unfit by the rhinologists/respirologist for bronchoscopy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathology (histological assessment)	1 day	Objective is to characterize the pathology (histological assessment) of 'diseased' and 'non-diseased' tissue in CRS patients undergoing sinus surgery as assessed by their pre-surgery CT scan results and stratify based on comorbid lung disease
Gene Expression Patterns	1 day	Objective is to compare the upper and lower airway pathology and gene expression patterns with in patients with CRS +/- asthma compare to non-CRS patients

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, B.C., Canada