Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

NCT06072690 | Recruiting

• 1 other identifier: COPDCVS1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe; Cardiovascular Diseases; Quality of Life

Keywords

COPD; cardiac autonomic integrity; cardiac function; dual bronchodilation; biomarkers; quality of life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

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

  Baseline to 12 weeks

• Change in forced vital capacity after 12 weeks of dual bronchodilation

  Baseline to 12 weeks

• Change in residual volume after 12 weeks of dual bronchodilation

  Baseline to 12 weeks

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

  Baseline to 12 weeks

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

  Baseline to 12 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, Kaunas County, 44307, Lithuania

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Skaidrius Miliauskas, PhD, Prof.

  Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Skaidrius Miliauskas, PhD, Prof.

CONTACT

+37037326269; skaidrius.miliauskas@lsmu.lt

Ieva Dimiene, MD

CONTACT

+3737326953; ieva.dimiene@lsmu.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonology Department, Professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: April 15, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

LI (1)