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

Not yet recruiting

• Conditions: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Chronic Cough (CC)

• Registration Number: NCT06858748
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Study Start: 2025-06
• Primary Completion: 2027-12
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Computed Tomography mucus score	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

Trial Locations

Locations (6)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Robarts Research Institute; 🇨🇦 London, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Quebec Heart and Lung Institute - Laval University; 🇨🇦 Quebec City, Quebec, Canada

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada