Unified Airway Model

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937427
• Other study ID #: H16-01176
• Status: Recruiting
• Start date: January 16, 2017
• Est. completion date: April 2020

Study information

• Verified date: May 2019
• Source: University of British Columbia
• Contact: India Dhillon, BSc
• Phone: 604-806-8353
• Email: idhillon3[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: April 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	B.C.

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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