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临床试验/NCT06858748
NCT06858748招募中不适用

Canadian Consortium for Understanding the Role of Airway Mucus Occlusions in Asthma, COPD and Chronic Cough

McMaster University12 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
12
主要终点
Computed Tomography mucus score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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\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

排除标准

  • •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

研究组 & 干预措施

Asthma

干预措施: Observational (Other)

Control group

干预措施: Observational (Other)

Chronic cough

Chronic Obstructive Pulmonary Disease (COPD)

干预措施: Observational (Other)

结局指标

主要结局

Computed Tomography mucus score

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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