Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Official title

The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease

Overview

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.

Primary outcome measures

• Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in health-related quality of life after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]

Secondary outcome measures (12)

• Change in forced expiratory volume in 1 second after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in forced vital capacity after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in residual volume after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in residual volume to total lung capacity ratio after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in right ventricular strain after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]
• Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation [Time frame: Baseline to 12 weeks]

Eligibility criteria

Inclusion criteria

• Aged 40 years and older
• Smoking index of 10 pack-years and more
• Newly diagnosed chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 30-79 percent of predicted and forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) less than 70 percent of predicted.

Exclusion criteria

• Active lung infection
• Present or previously treated lung cancer
• Alpha-1 antitrypsin deficiency
• Diagnosed interstitial lung disease
• Previously diagnosed asthma
• Diagnosed chronic hypercapnic respiratory failure
• Treatment with systemic glucocorticoids
• Unstable ischaemic heart disease
• Pregnancy
• Present cardiac arrhythmias
• Uncontrolled arterial hypertension
• Dementia and other mental states that determine patient's inability to consent
• Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Lithuania · 1 center

• Lithuanian University of Health Sciences — Kaunas

Publications

• 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: 10.1177/175346662614 PMID 42339592

Identifiers

NCT: NCT06072690 · COPDCVS1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗