Refractory Breathlessness in COPD
ConditionCOPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSeoul National University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
End-stage diseases with life expectancy < 1 year.
Terminal malignancies receiving hospice or palliative care.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
730 Participants
are grouped into 1 trial groupGroup A: COPD patients with refractory breathlessness despite LABA/LAMA therapy
Trial outcomes
Primary outcomes
1
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)2
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.Secondary outcomes
1
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.2
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.Other outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov