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出境医 / 临床实验 / Unified Airway Model
Unified Airway Model
Study Description
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.
| Condition or disease |
|---|
| Chronic Rhinosinusitis (Diagnosis) Asthma |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 24 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Unified Airway Model: Comparison of the Microbiome of the Upper and Lower Airways in Chronic Rhinosinusitis and Asthma Patients |
| Study Start Date : | January 16, 2017 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | April 2020 |
Arms and Interventions
| Group/Cohort |
|---|
| CRS with Asthma |
| CRS without Asthma |
Outcome Measures
Primary Outcome Measures :
- Pathology (histological assessment) [ Time Frame: 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 [ Time Frame: 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
Eligibility Criteria
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
Criteria
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.
Contacts and Locations
Contacts
| Contact: India Dhillon, BSc | 604-806-8353 | idhillon3@providencehealth.bc.ca |
Locations
| Canada, B.C. | |
| St. Paul's Hospital | Recruiting |
| Vancouver, B.C., Canada, V6Z 1Y6 | |
| Contact: India Dhillon, BSc 6048069926 idhillon3@providencehealth.bc.ca | |
| Sub-Investigator: Amin Javer, MD | |
| Sub-Investigator: Janice Leung, MD | |
| Sub-Investigator: Don Sin, MD | |
| Sub-Investigator: Tawimas Shaipanich, MD | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Andrew Thamboo, MD | University of British Columbia |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 1, 2019 | ||||
| First Posted Date | May 3, 2019 | ||||
| Last Update Posted Date | May 3, 2019 | ||||
| Study Start Date | January 16, 2017 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Unified Airway Model | ||||
| Official Title | Unified Airway Model: Comparison of the Microbiome of the Upper and Lower Airways in Chronic Rhinosinusitis and Asthma Patients | ||||
| 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 Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
24 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | April 2020 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 19 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03937427 | ||||
| Other Study ID Numbers | H16-01176 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Andrew Thamboo, University of British Columbia | ||||
| Study Sponsor | University of British Columbia | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | University of British Columbia | ||||
| Verification Date | May 2019 | ||||
