Persistent breathlessness in people with COPD despite LABA/LAMA treatment

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

See if clinical signs, lung function, imaging, and heart tests can predict worse outcomes in people with COPD who still have breathlessness after at least three months on LABA/LAMA inhalers.

Quick facts

• Study type: Observational
• Enrollment: 730 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Seoul National University (other)
• Locations: 1 site (Seoul, Seoul)
• Trial ID: NCT07160322 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort enrolling adults with GOLD-defined COPD who have used LABA/LAMA therapy for at least three months and are followed in outpatient clinics in Seoul. Baseline evaluation includes symptoms, comorbidities, spirometry and lung volumes, exercise testing, chest CT and radiography, echocardiography, and blood biomarkers, with serial follow-up for exacerbations, lung function decline, exercise capacity, and survival. Participants will be classified into refractory and improved symptom groups based on mMRC and CAT changes, and multivariable and predictive models will be used to identify factors associated with poor outcomes. The study aims to translate identified predictors into targeted strategies to improve management of persistent dyspnea in COPD.

Who should consider this trial

Good fit: Adults (≥18) with GOLD-defined COPD who have been on LABA/LAMA combination therapy for at least 3 months and are able to attend regular outpatient follow-up at the participating Seoul centers.

Not a fit: Patients with poor adherence to LABA/LAMA therapy, terminal comorbidities with life expectancy under one year, or inability to complete clinic visits and testing are unlikely to benefit from the study's profiling approach.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at higher risk of exacerbations or decline and guide more personalized management to reduce symptoms and adverse outcomes.

How similar studies have performed: Previous cohort studies have identified clinical and imaging predictors of COPD outcomes, but prospective focused profiling of patients with refractory dyspnea on LABA/LAMA is relatively limited, so this approach is partly supported but still fills a knowledge gap.

Eligibility criteria

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 this trial is running

Seoul, Seoul

• Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul, Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Hyun Woo Lee, M.D.

Conditions: COPD, Chronic Obstructive Pulmonary Disease, Refractory Breathlessness, Persistent Dyspnea, Treatment Resistance, Unresponsive to Therapy