Persistent breathlessness in people with COPD despite LABA/LAMA treatment
Official title: Prognosis and Clinical Outcomes of Refractory Dyspnea in Chronic Obstructive Pulmonary Disease: Prospective Observational Study
Run by Seoul National University · NCT07160322 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 730 (estimated) |
| Sponsor | Seoul National University Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | April 11, 2024 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2031 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT07160322 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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.
- Email: athrunzara86@snu.ac.kr
- Phone: 82-10-9755-6172
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer
This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.
-
Cognitive load and inhaler technique in COPD
This study tests whether adding a short memory task while using an inhaler makes COPD patients more likely to misuse their inhaler.
-
Balance training after pulmonary rehab for COPD to help steadiness and reduce falls
A COPD-focused balance training program called Sport4Steadiness is being tested to see if people with COPD will accept it and if the study processes work well.
-
Continuous vs High-Intensity Interval Exercise in COPD
This study tests whether continuous versus high-intensity interval exercise affects cerebral oxygenation in people with COPD.
-
Biomarker clues for COPD, IPF, and lung cancer
This study tests whether inflammation, immune, genetic, and epigenetic markers at enrollment can explain how COPD, IPF, or lung cancer present and behave, in order to see if these markers can predict outcomes over a year.
-
HRS-9821 Inhalation Suspension for COPD: Safety and Dose Finding in Adults
This study tests whether HRS-9821 inhalation can be safely taken and help people with moderate to severe COPD, and aims to find a reasonable dose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.