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NCT Number: NCT06072690

Respiratory and Cardiovascular Alterations in Patients With 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Moderate Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Severe Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Quality of Life Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lithuanian University of Health Sciences

Kaunas, Kaunas County, 44307, Lithuania

Location status: Recruiting

Location contact

Rimantas Benetis, PhD, Prof.

CONTACT

[email protected]

+37037327200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on peak oxygen uptake (VO2) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

  2. Change in health-related quality of life after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

Secondary outcomes

  1. Change in forced expiratory volume in 1 second after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  2. Change in forced vital capacity after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on forced vital capacity (FVC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

  3. Change in residual volume after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on residual volume (RV) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

  4. Change in residual volume to total lung capacity ratio after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  5. Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  6. Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  7. Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  8. Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on right ventricle end-systolic volume index (RVESVi) in patients with newly diagnosed moderate-to-severe COPD

  9. Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on right ventricle end-diastolic volume index (RVEDVi) in patients with newly diagnosed moderate-to-severe COPD

  10. Change in right ventricular strain after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on right ventricular (RV) strain in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease

  11. Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on left ventricle end-systolic volume index (LVESVi) in patients with newly diagnosed moderate-to-severe COPD

  12. Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on left ventricle end-diastolic volume index (LVEDVi) in patients with newly diagnosed moderate-to-severe COPD

  13. Change in stroke volume index after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    The effect of dual bronchodilation on stroke volume index (SVi) in patients with newly diagnosed moderate-to-severe COPD

  14. Change in washout rate after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  15. Change in heart to mediastinum ratio after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  16. Change in left ventricle total defect score after 12 weeks of dual bronchodilation

    Time frame: Baseline to 12 weeks

    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

  17. Differences in health-related quality of life between COPD and non-COPD individuals

    Time frame: Baseline

  18. Differences in exercise capacity between COPD and non-COPD individuals

    Time frame: Baseline

  19. Differences in right ventricular (RV) measurements between COPD and non-COPD individuals

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Ieva Dimiene, MD

CONTACT

[email protected]

+3737326953

Skaidrius Miliauskas, PhD, Prof.

CONTACT

[email protected]

+37037326269

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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