NCT06072690 Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
| NCT ID | NCT06072690 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lithuanian University of Health Sciences |
| Condition | Chronic Obstructive Pulmonary Disease Moderate |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-04-15 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2021-04-15 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Skaidrius Miliauskas, PhD, Prof.
PRINCIPAL INVESTIGATOR
Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
Frequently Asked Questions
Who can join the NCT06072690 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Chronic Obstructive Pulmonary Disease Moderate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06072690 currently recruiting?
Yes, NCT06072690 is actively recruiting participants. Contact the research team at skaidrius.miliauskas@lsmu.lt for enrollment information.
Where is the NCT06072690 trial being conducted?
This trial is being conducted at Kaunas, Lithuania.
Who is sponsoring the NCT06072690 clinical trial?
NCT06072690 is sponsored by Lithuanian University of Health Sciences. The principal investigator is Skaidrius Miliauskas, PhD, Prof. at Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology. The trial plans to enroll 80 participants.