RecruitingNCT07160322

Refractory Breathlessness in COPD

Prognosis and Clinical Outcomes of Refractory Dyspnea in Chronic Obstructive Pulmonary Disease: Prospective Observational Study


Sponsor

Seoul National University

Enrollment

730 participants

Start Date

Apr 11, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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.

Locations(1)

Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, Seoul, South Korea

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NCT07160322


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