Clinical trial NCT06858748: Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Official title: Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Cough (CC)
Keywords: mucus occlusions
asthma
Chronic Cough (CC)
Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A coalition of 25 clinicians and scientists from across Canada have united to establish the Canadian Consortium for understanding the role of airway mucus occlusions in chronic cough, COPD, and asthma (CANMuc).

Brief summary: Chronic lung diseases affect one in five Canadians, causing symptoms such as cough, breathlessness, and wheeze. Despite advancements in medical care, these conditions not only impact individuals and their close circles but also present substantial clinical and economic challenges at a national level. This grant is dedicated to addressing three prevalent lung diseases: asthma, chronic obstructive pulmonary disease (COPD), and chronic cough. An alliance of clinicians, scientists, knowledge users, and patient partners from across Canada have come together to establish the Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD, and Chronic Cough - "CANMuc." Mucus plays a pivotal role in the symptoms and severity of lung diseases, but its clinical assessment has been challenging. Fortunately, recent medical advances, particularly chest computed tomography (CT), facilitate visualizing and quantifying mucus in patients with lung diseases. Our goal is to initially assess mucus plugging in a diverse group of Canadians without lung disease and then compare these findings to those with asthma, COPD, and chronic cough. The investigators will recruit 100 healthy volunteers for comprehensive clinical and research evaluations, including sputum analyses, breathing tests, quality of life assessments, cough monitoring, and CT scans. In addition, testing will be conducted twice, two years apart, in 240 adult and 50 pediatric participants. This approach will enable the investigators to understand the burden of mucus and how it changes over time, explore proteins or chemicals in mucus that predict mucus persistence, and identify biomarkers that can help guide physicians to prescribe targeted treatments that might work better than others. The CANMuc team's findings will guide strategies for identifying and treating mucus plugging, inform policymakers, and share knowledge with Canadians living with asthma, COPD, and chronic cough.


Eligibility criteria: 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

Primary outcomes:
measure: Computed Tomography mucus score
timeFrame: Baseline/Day 0 and End of Assessment/48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: London
country: Canada
facility: Robarts Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Quebec City
country: Canada
facility: Quebec Heart and Lung Institute - Laval University
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
References: