Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-11

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma Chronic Obstructive Pulmonary Disease (COPD) Chronic Cough (CC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthma

Observational

Intervention Type OTHER

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)

Observational

Intervention Type OTHER

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

Observational

Intervention Type OTHER

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

Control group

Observational

Intervention Type OTHER

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

Interventions

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Observational

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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