An observational study in COPD, sponsored by Seoul National University. Recruiting at 1 site in South Korea. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Seoul National University · Observational
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.
The study aims to identify actionable clinical factors and develop predictive models that can enhance personalized management approaches for patients with refractory dyspnea in COPD.
This is a prospective observational cohort study designed to characterize patients with COPD who remain symptomatic despite standard inhaled therapy with LABA/LAMA combination. Participants will be enrolled from outpatient clinics and followed over time to assess changes in respiratory symptoms, lung function, exercise capacity, acute exacerbation frequency, and survival.
Key assessments include:
Patients will be classified into two groups:
The primary analyses will explore clinical and physiological predictors of poor outcomes, using advanced statistical modeling such as linear mixed-effects models for longitudinal lung function trends, negative binomial regression for exacerbation risk, and Cox proportional hazards models for survival analysis.
Assessments:
Baseline and follow-up evaluations will include demographic and clinical data, comorbidities, smoking history, inhaler adherence and technique, spirometry, lung volume measurements, 6-minute walk tests, echocardiography, chest radiographs, and high-resolution CT scans. Blood tests will include complete blood count, inflammatory markers (C-reactive protein (CRP), fibrinogen), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and cardiac enzymes.
Statistical Analysis:
Longitudinal trends: Changes in lung function, symptoms, and exercise capacity will be assessed using linear mixed-effects models to evaluate the influence of clinical factors.
Acute exacerbations: The frequency of moderate-to-severe exacerbations will be analyzed using negative binomial regression or zero-inflated models when appropriate.
Mortality: Logistic regression will estimate 1-, 3-, and 5-year mortality risk, while Cox proportional hazards models will evaluate time-to-event outcomes.
Predictive modeling: Candidate biomarkers and imaging features will be incorporated into multivariable predictive models to identify key determinants of poor prognosis.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 730 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll adult patients (≥ 18 years) diagnosed with chronic obstructive pulmonary disease (COPD) according to the GOLD 2025 criteria, who are receiving combination therapy with long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA). Participants include both patients who continue to experience refractory dyspnea despite treatment and those who show symptomatic improvement. All participants must be able to attend regular outpatient visits and provide written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of severe comorbid conditions expected to significantly affect prognosis, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Annual rate of acute exacerbations in COPD
Annualized rate of moderate-to-severe exacerbations per patient-year, defined as episodes requiring systemic corticosteroids, antibiotics, or hospitalization. Moderate exacerbations will be defined as events requiring treatment with systemic corticosteroids and/or antibiotics without hospitalization. Severe exacerbations will be defined as events leading to hospitalization or emergency department visit. Unit: Number of exacerbations per patient-year
Time frame: Up to 5 years (annualized rate)
All-cause mortality
Proportion of participants who die from any cause Unit: Percentage of participants (%) or Number of deaths
Time frame: 1-, 3-, and 5-year follow-up.
Annual forced expiratory volume in one second (FEV1) decline rate
Rate of change in forced expiratory volume in one second (FEV1) (Milliliters per year (mL/year)) measured by spirometry Annual decline in FEV1 will be assessed using linear mixed-effects models.
Time frame: Baseline and annually for up to 5 years.
Annual forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC ratio) decline rate
Rate of change in post-bronchodilator forced expiratory volume in one second to forced vital capacity (FEV1/FVC ) ratio (%/year) measured by spirometry Annual decline in FEV1/FVC will be assessed using linear mixed-effects models.
Time frame: Baseline and annually for up to 5 years.
Change in modified Medical Research Council (mMRC) dyspnea scores from baseline
Mean change in mMRC score from baseline Unit: Score units (0-4 scale)
Time frame: Baseline, 3-6 months, and annually for up to 5 years.
Change in CAT scores from baseline
Mean change in CAT score from baseline Unit: Score units (0-40 scale)
Time frame: Baseline, 3-6 months, and annually for up to 5 years.
Change in Charlson Comorbidity Index (CCI) from baseline
Mean change in CCI score Unit: Score units
Time frame: Baseline and annually for up to 5 years.
Change in COPD-specific Comorbidity Test (COTE) index from baseline
Mean change in COTE index Unit: Score units
Time frame: Baseline and annually for up to 5 years.
Change in COPD Comorbidity (COMCOLD) index from baseline
Mean change in COMCOLD index Unit: Score units
Time frame: Baseline and annually for up to 5 years.
Change in medication possession rate (MPR) from baseline
Mean change in MPR, expressed as % of days with medication available Unit: Percentage (%)
Time frame: Baseline and annually for up to 5 years.
Change in proportion of days covered (PDC) from baseline
Mean change in PDC, expressed as % of days with medication available Unit: Percentage (%)
Time frame: Baseline and annually for up to 5 years.
Change in white blood cell (WBC) from baseline
Mean change in WBC count from baseline Unit: ×10⁹ cells/L
Time frame: Baseline and annually for up to 5 years.
Change in blood eosinophil count (BEC) from baseline
Mean change in BEC from baseline Unit: cells/L
Time frame: Baseline and annually for up to 5 years.
Change in immunoglobulin E (IgE) from baseline
Mean change in IgE from baseline Unit: International Units per milliliter (IU/mL)
Time frame: Baseline and annually for up to 5 years.
Change in fibrinogen from baseline
Mean change in fibrinogen from baseline Unit: milligrams per deciliter (mg/dL)
Time frame: Baseline and annually for up to 5 years.
Change in cortisol from baseline
Mean change in cortisol measured at 8 AM from baseline Unit: micrograms per deciliter (µg/dL)
Time frame: Baseline and annually for up to 5 years.
Change in C-reactive protein (CRP) from baseline
Mean change in CRP from baseline Unit: milligrams per liter (mg/L)
Time frame: Baseline and annually for up to 5 years.
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline
Mean change in NT-proBNP from baseline Unit: picograms per milliliter (pg/mL)
Time frame: Baseline and annually for up to 5 years.
Change in Troponin I from baseline
Mean change in Troponin I from baseline Unit: nanograms per milliliter (ng/mL)
Time frame: Baseline and annually for up to 5 years.
Change in difference between respiratory resistance at 5 Hz and 20 Hz (R5-R20) from baseline
Mean change in R5-R20 from baseline Unit: cmH₂O/L/s
Time frame: Baseline and annually for up to 5 years.
Change in resonant frequency (Fres) from baseline
Mean change in Fres from baseline Unit: Hertz (Hz)
Time frame: Baseline and annually for up to 5 years.
Change in reactance at 5 Hz (X5) from baseline
Mean change in X5 from baseline Unit: cmH₂O/L/s
Time frame: Baseline and annually for up to 5 years.
Change in area of reactance (AX) from baseline
Mean change in AX from baseline Unit: cmH₂O/L
Time frame: Baseline and annually for up to 5 years.
Change in parametric response mapping of functional small airway disease (PRMfSAD) in chest CT from baseline
Mean change in PRMfSAD from baseline Unit: Percentage of lung volume (%)
Time frame: Baseline and annually for up to 5 years.
Change in low attenuation area in inspiratory chest CT from baseline
Mean change in low attenuation area (\<-950 Hounsfield unit (HU)) in inspiratory chest CT from baseline Unit: Percentage of lung volume (%)
Time frame: Baseline and annually for up to 5 years.
Change in low attenuation area in expiratory chest CT from baseline
Mean change in low attenuation area (\<-856 hounsfield unit (HU)) in expiratory chest CT from baseline Unit: Percentage of lung volume (%)
Time frame: Baseline and annually for up to 5 years.
Change in square root of wall area for a theoretical airway with 10 mm internal perimeter (Pi10) in chest CT from baseline
Mean change in square root of wall area for a theoretical airway with 10 mm internal perimeter (Pi10) from baseline Unit: millimeters (mm)
Time frame: Baseline and annually for up to 5 years.
Plan to share: No — Individual participant data will not be shared because the dataset contains sensitive personal health information, and there are no current plans or infrastructure for secure data sharing. Data will be used solely for analyses specified in the approved protocol and will remain confidential in accordance with institutional and IRB guidelines.
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Pulmonary Disease, Chronic Obstructive →
Seoul National University