Refractory Breathlessness in COPD
Recruiting · NCT07160322 · Observational (researchers observe without assigning treatment) · Lead sponsor: Seoul National University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 \< 0.70.
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center - Seoul, Seoul, South Korea