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

NCT06858748 | Recruiting

• 1 other identifier: CANMuc01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

mucus occlusions; asthma; Chronic Cough (CC); Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Computed Tomography mucus score

  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

Study Arms (4)

Asthma

Other: Observational

Chronic Obstructive Pulmonary Disease (COPD)

Other: Observational

Chronic cough

Other: Observational

Control group

Other: Observational

Interventions

Observational 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

Asthma; Chronic Obstructive Pulmonary Disease (COPD); Chronic cough; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (6)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Robarts Research Institute

London, Ontario, N6A 5B7, Canada

NOT YET RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

Quebec Heart and Lung Institute - Laval University

Québec, Quebec, G1V 4G5, Canada

NOT YET RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, PBMC, sputum

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Chronic Cough

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cough; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

CA (6)