Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Quality of Life; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Skaidrius Miliauskas, PhD, Prof.; Phone Number: +37037326269; Email: skaidrius.miliauskas@lsmu.lt
• Study Contact Backup: Name: Ieva Dimiene, MD; Phone Number: +3737326953; Email: ieva.dimiene@lsmu.lt

Study Locations

• Lithuania
  • Kaunas County
    • Kaunas, Kaunas County, Lithuania, 44307
      • Recruiting
      • Lithuanian University of Health Sciences
      • Contact: Rimantas Benetis, PhD, Prof.; Phone Number: +37037327200; Email: rektoratas@lsmuni.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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 right ventricular (RV) measurements between COPD and non-COPD individuals		Baseline

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Skaidrius Miliauskas, PhD, Prof., Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; quality of life; COPD; cardiac function; cardiac autonomic integrity; dual bronchodilation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases
• Other Study ID Numbers: COPDCVS1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No