Unified Airway Model

Unified Airway Model: Comparison of the Microbiome of the Upper and Lower Airways in Chronic Rhinosinusitis and Asthma Patients

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.

Study Overview

• Status: Unknown
• Conditions: Asthma; Chronic Rhinosinusitis (Diagnosis)

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Canada
  • B.C.
    • Vancouver, B.C., Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital
      • Contact: India Dhillon, BSc; Phone Number: 6048069926; Email: idhillon3@providencehealth.bc.ca
      • Sub-Investigator: Amin Javer, MD
      • Sub-Investigator: Janice Leung, MD
      • Sub-Investigator: Don Sin, MD
      • Sub-Investigator: Tawimas Shaipanich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will analyze and compare the upper and lower airways from 12 CRS with asthma patients and 12 CRS without asthma patients matched for age, sex and degree of sinus disease based on CT grading using Lund-Mackay staging system.14

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CRS with Asthma
CRS without Asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathology (histological assessment)	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	1 day
Gene Expression Patterns	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	1 day

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start: January 16, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: H16-01176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No