Prognosis and Clinical Outcomes of Refractory Dyspnea in Chronic Obstructive Pulmonary Disease: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Annual rate of acute exacerbations in COPD
研究概览
简要总结
This study aims to investigate the prognosis and clinical outcomes of patients with chronic obstructive pulmonary disease (COPD) who continue to experience refractory dyspnea despite treatment with long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA). The research will prospectively follow a cohort of patients to identify clinical factors, lung function parameters, imaging features, and cardiovascular indicators associated with poor treatment response. By comparing these patients with those who show symptom improvement, the study seeks to determine predictors of exacerbations, lung function decline, and mortality. Findings are expected to guide the development of targeted strategies to improve the management of refractory dyspnea in COPD.
详细描述
The study aims to identify actionable clinical factors and develop predictive models that can enhance personalized management approaches for patients with refractory dyspnea in COPD.
This is a prospective observational cohort study designed to characterize patients with COPD who remain symptomatic despite standard inhaled therapy with LABA/LAMA combination. Participants will be enrolled from outpatient clinics and followed over time to assess changes in respiratory symptoms, lung function, exercise capacity, acute exacerbation frequency, and survival.
Key assessments include:
- Baseline demographic and clinical data (e.g., respiratory symptoms, comorbidities, smoking history).
- Pulmonary function tests (spirometry and lung volumes), exercise capacity evaluations, echocardiography, chest radiographs, and computed tomography (CT).
- Biomarker analysis (blood tests including inflammatory and cardiac markers).
Patients will be classified into two groups:
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years) diagnosed with chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2025 criteria:
- •Presence of COPD risk factors (e.g., smoking history, occupational exposure, genetic predisposition).
- •Typical symptoms such as dyspnea, cough, or sputum production.
- •Post-bronchodilator FEV1/FVC < 0.
- •Regular outpatient follow-up at the respiratory clinic.
- •Received LABA/LAMA combination therapy for at least 3 months prior to enrollment.
- •Ability and willingness to provide written informed consent.
排除标准
- •Poor adherence to LABA/LAMA therapy (medication possession rate < 50%) or refusal of treatment.
- •Inability or unwillingness to comply with scheduled visits, examinations, or follow-up procedures.
- •Presence of severe comorbid conditions expected to significantly affect prognosis, including:
- •End-stage diseases with life expectancy < 1 year.
- •Terminal malignancies receiving hospice or palliative care.
- •Any condition that, in the opinion of the investigator, would interfere with study participation or data reliability.
结局指标
主要结局
Annual rate of acute exacerbations in COPD
时间窗: Up to 5 years (annualized rate)
Annualized rate of moderate-to-severe exacerbations per patient-year, defined as episodes requiring systemic corticosteroids, antibiotics, or hospitalization. Moderate exacerbations will be defined as events requiring treatment with systemic corticosteroids and/or antibiotics without hospitalization. Severe exacerbations will be defined as events leading to hospitalization or emergency department visit. Unit: Number of exacerbations per patient-year
All-cause mortality
时间窗: 1-, 3-, and 5-year follow-up.
Proportion of participants who die from any cause Unit: Percentage of participants (%) or Number of deaths
次要结局
- Annual forced expiratory volume in one second (FEV1) decline rate(Baseline and annually for up to 5 years.)
- Annual forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC ratio) decline rate(Baseline and annually for up to 5 years.)
研究者
Hyun Woo Lee
Assistant professor
Seoul National University