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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center
RECRUITING
Seoul
Contact Information
Primary
Hyun Woo Lee, M.D.
athrunzara86@snu.ac.kr
82-10-9755-6172
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 730
Treatments
COPD patients with refractory breathlessness despite LABA/LAMA therapy
Patients with COPD who continue to experience clinically significant dyspnea (mMRC ≥ 2 or CAT ≥ 10) despite at least 3 months of treatment with dual long-acting bronchodilator therapy (LABA/LAMA), showing less than a 1-point reduction in mMRC or less than a 4-point reduction in CAT scores compared with baseline.
Sponsors
Leads: Seoul National University

This content was sourced from clinicaltrials.gov