Chronic Rhinosinusitis (Diagnosis)NCT03937427
Unified Airway Model
An observational study of Chronic Rhinosinusitis (Diagnosis) and Asthma, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Asthma
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2017to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, B.C., V6Z 1Y6
India Dhillon, BSc, 6048069926, idhillon3@providencehealth.bc.ca
Amin Javer, MD
About this study
Official title: 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.
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Asthma
- Medical subject headings
- Disease, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRS with Asthma | Not described | |
| CRS without Asthma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start16 Jan 2017
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Thamboo, University of British Columbia
- Investigators
- Andrew Thamboo, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937427
- Sponsor's protocol ID
- H16-01176
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Airway Model: Comparison of the Microbiome of the Upper and Lower Airways in Chronic Rhinosinusitis and Asthma Patients
- ClinicalTrials.gov ID
- NCT03937427
- Acronym / sponsor ID
- H16-01176
- Conditions
- Chronic Rhinosinusitis (Diagnosis), Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 16 Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRS with Asthma | – | – |
| CRS without Asthma | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Oral antibiotics in the past month prior to surgery;
- Immunocompromised;
- Prior lung transplants;
- Known sinonasal or bronchial tumors, current or previous;
- Smoking;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Thamboo, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (Diagnosis) and Asthma, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact India Dhillon, BSc (604-806-8353, idhillon3@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology (histological assessment) (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.