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Chronic obstructive pulmonary disease (COPD) is a lung condition characterized by chronic respiratory symptoms (dyspnoea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (e.g. bronchitis, bronchiolitis) and/or alveoli (emphysema) that lead to persistent, often progressive, airflow obstruction.
It is a major cause of disability and death worldwide. Moreover, people with COPD often have cardiovascular diseases (CVDs) that are associated with increased risk for hospitalization and prolonged stay as well as all-cause and CVD-related mortality. Nevertheless, CVDs in patients with COPD are tend to be underestimated in clinical practice. Mechanisms that define the relation between COPD and cardiovascular morbidity include lung hyperinflation, hypoxia, pulmonary hypertension, systemic inflammation and oxidative stress, exacerbation, shared risk factors and COPD phenotypes. In the past years, some authors have announced that COPD treatment with dual bronchodilation may not only improve pulmonary function and quality of life, but also have a positive effect on cardiac function. However, there is a lack of studies with treatment-naïve patients that would describe the initial effect of dual bronchodilation on respiratory and cardiovascular systems. In this study we aimed to evaluate the effect of initial dual bronchodilation on the quality of life, respiratory and cardiovascular systems in patients with newly-diagnosed chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD group | Patients of any gender aged 40 years and older with newly diagnosed treatment-naive moderate-to-severe chronic obstructive pulmonary disease will have a comprehensive cardiovascular and respiratory examination as well as evaluation of quality of life before the treatment and after 12 weeks of treatment with dual bronchodilation. | ||
| Non-COPD group | Subjects 40 years and older without respiratory conditions with similar age, gender and cardiovascular comorbidity profile |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on peak oxygen uptake (VO2) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in health-related quality of life after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on health related quality of life (evaluating using the Short Form 36 Health Survey (SF-36) Questionnaire) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forced expiratory volume in 1 second after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on forced expiratory volume in 1 second (FEV1) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in forced vital capacity after 12 weeks of dual bronchodilation |
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Inclusion Criteria:
Exclusion Criteria:
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The cohort will be selected from patients with clinical signs of COPD reffered to the tertiary care outpatient clinic by general physicians from the primary and secondary care clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Skaidrius Miliauskas, PhD, Prof. | Contact | +37037326269 | skaidrius.miliauskas@lsmu.lt | |
| Ieva Dimiene, MD | Contact | +3737326953 | ieva.dimiene@lsmu.lt |
| Name | Affiliation | Role |
|---|---|---|
| Skaidrius Miliauskas, PhD, Prof. | Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lithuanian University of Health Sciences | Recruiting | Kaunas | Kaunas County | 44307 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42339592 | Derived | Dimiene I, Neverauskaite-Piliponiene G, Bucius P, Simkus P, Padervinskiene L, Rimkunas A, Ereminiene E, Miliauskas S. Effects of dual bronchodilation on right ventricular function and troponin-I in newly diagnosed, moderate-to-severe chronic obstructive pulmonary disease: a prospective real-world observational study. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261452491. doi: 10.1177/17534666261452491. Epub 2026 Jun 24. |
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The effect of dual bronchodilation on forced vital capacity (FVC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease |
| Baseline to 12 weeks |
| Change in residual volume after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on residual volume (RV) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in residual volume to total lung capacity ratio after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on residual volume to total lung capacity ratio (RV/TLC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on forced residual capacity to total lung capacity ratio (FRC/TLC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on the structure of segmental bronchi measured in CT scan in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on right ventricle end-systolic volume index (RVESVi) in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on right ventricle end-diastolic volume index (RVEDVi) in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in right ventricular strain after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on right ventricular (RV) strain in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease | Baseline to 12 weeks |
| Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on left ventricle end-systolic volume index (LVESVi) in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on left ventricle end-diastolic volume index (LVEDVi) in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in stroke volume index after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on stroke volume index (SVi) in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in washout rate after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on washout rate (WR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in heart to mediastinum ratio after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on early and late heart to mediastinum ratio (HMR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Change in left ventricle total defect score after 12 weeks of dual bronchodilation | The effect of dual bronchodilation on early and late left ventricle early total defect score (TDS) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD | Baseline to 12 weeks |
| Differences in health-related quality of life between COPD and non-COPD individuals | Baseline |
| Differences in exercise capacity between COPD and non-COPD individuals | Baseline |
| Differences in right ventricular (RV) measurements between COPD and non-COPD individuals | Baseline |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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