NCT06858748 Canadian Consortium on Airway Mucus Occlusions in Asthma, COPD and Chronic Cough
| NCT ID | NCT06858748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2025-12-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT06858748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06858748 currently recruiting?
Yes, NCT06858748 is actively recruiting participants. Visit ClinicalTrials.gov or contact McMaster University to inquire about joining.
Where is the NCT06858748 trial being conducted?
This trial is being conducted at Vancouver, Canada, Hamilton, Canada, London, Canada, Ottawa, Canada and 2 additional locations.
Who is sponsoring the NCT06858748 clinical trial?
NCT06858748 is sponsored by McMaster University. The trial plans to enroll 240 participants.
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