Refractory Breathlessness in COPD

NCT07160322 | Recruiting DMC

• 1 other identifier: 2024-0434
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Refractory Breathlessness; Persistent Dyspnea; Treatment Resistance; Unresponsive to Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1-, 3-, and 5-year follow-up.

Secondary Outcomes (2)

• Annual forced expiratory volume in one second (FEV1) decline rate

  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

  Baseline and annually for up to 5 years.

Other Outcomes (23)

• Change in modified Medical Research Council (mMRC) dyspnea scores from baseline

  Baseline, 3-6 months, and annually for up to 5 years.

• Change in CAT scores from baseline

  Baseline, 3-6 months, and annually for up to 5 years.

• Change in Charlson Comorbidity Index (CCI) from baseline

  Baseline and annually for up to 5 years.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University College of Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, Seoul, 07061, South Korea

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Hyun Woo Lee, M.D.

CONTACT

82-10-9755-6172; athrunzara86@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: September 8, 2025
• Study Start: April 11, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: September 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)