- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06858748
Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough (CANMuc)
Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Not yet recruiting
- St. Paul's Hospital
-
Contact:
- Don Sin
- Phone Number: 604-806-9033
- Email: Don.Sin@hli.ubc.ca
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- Recruiting
- St. Joseph's Healthcare Hamilton
-
Contact:
- Manali Mukherjee
- Phone Number: 35594 905-522-1155
- Email: mukherj@mcmaster.ca
-
London, Ontario, Canada, N6A 5B7
- Not yet recruiting
- Robarts Research Institute
-
Contact:
- Grace Parraga
- Phone Number: 24197 519-931-5777
- Email: gparraga@uwo.ca
-
Ottawa, Ontario, Canada, K1H 8L6
- Not yet recruiting
- The Ottawa Hospital
-
Contact:
- Shawn Aaron
- Phone Number: (613) 737-8259
- Email: SAARON@toh.ca
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Not yet recruiting
- Quebec Heart and Lung Institute - Laval University
-
Contact:
- Andréanne Cote
- Email: andreanne.cote@criucpq.ulaval.ca
-
Sherbrooke, Quebec, Canada, J1H 5N4
- Not yet recruiting
- Université de Sherbrooke
-
Contact:
- Simon Couillard
- Phone Number: 819-821-8000
- Email: Simon.Couillard2@USherbrooke.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Males and females (≥18 years old)
Asthma: Respiratory physician confirmed diagnosis of moderate-to-severe asthma and Historical objective evidence of asthma and/or specialist/respirologist confirmation (post-bronchodilator reversibility and/or methacholine bronchoprovocation test <8 mg/mL)
COPD: Respiratory physician confirmed diagnosis of COPD that is moderate-to-severe according to GOLD criteria (post-bronchodilator FEV1/FVC<LLN and FEV1< 80%pred) and CAT score ≥10 or mMRC score ≥ 2
Chronic cough: Refractory Chronic Cough (RCC) and Unexplained Chronic Cough (UCC) lasting >1 year with Normal chest radiograph and no airflow obstruction (FEV1/FVC >Lower Limit of Normal)
Healthy participants: No history of respiratory disease or other pulmonary disorders and no use of inhaled medications or corticosteroids with normal spirometry and Modified Medical Research Council (mMRC) Dyspnea Scale =<1
Exclusion Criteria:
- Pregnant or breastfeeding
- Current smoker or >10 yr pack history or smoked within the last 6 months
- Exacerbation within 4 weeks of recruitment
- Preterm birth (≤36 weeks gestation) or perinatal complications
- History of other pulmonary disorders
- Specialist/Respirologist suspects primary ciliary dyskinesia (PCD)
- Current use of mucolytic medications
- Memory, cognitive, or psychiatric limitations that may prevent optimal participation
- Treatment with current biologic therapy: anti-IgE mAb within 130 days, anti-IL-4/4R, IL-5/5R, IL-13, or TSLP within 2 months or 5 half-lives whichever is longer prior to visit 1
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
|
This is a 24-month observational study in adults in three disease domains, consisting of screening visit, baseline visit, quarterly telemonitoring visit and end of monitoring period
|
|
Asthma
|
This is a 24-month observational study in adults in three disease domains, consisting of screening visit, baseline visit, quarterly telemonitoring visit and end of monitoring period
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
This is a 24-month observational study in adults in three disease domains, consisting of screening visit, baseline visit, quarterly telemonitoring visit and end of monitoring period
|
|
Chronic cough
|
This is a 24-month observational study in adults in three disease domains, consisting of screening visit, baseline visit, quarterly telemonitoring visit and end of monitoring period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Computed Tomography mucus score
Time Frame: Baseline/Day 0 and End of Assessment/48 months
|
Quantify CT mucus score and evaluate its cross-sectional and longitudinal relationship with sputum rheology and inflammatory phenotype in a healthy cohort compared to disease groups at baseline and follow-up
|
Baseline/Day 0 and End of Assessment/48 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Immune System Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Signs and Symptoms, Respiratory
- Cough
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Cough
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Health Services Administration
- Quality of Health Care
- Outcome Assessment, Health Care
- Outcome and Process Assessment, Health Care
- Watchful Waiting
Other Study ID Numbers
- CANMuc01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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