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Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
NCT06072690 · Lithuanian University of Health Sciences
In plain English
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Official title
The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease
About this study
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
Study design
Enrollment target: 80 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-04-15
Estimated completion: 2026-08-31
Last updated: 2026-04-02
Primary outcomes
- • Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation (Baseline to 12 weeks)
- • Change in health-related quality of life after 12 weeks of dual bronchodilation (Baseline to 12 weeks)
Sponsor
Lithuanian University of Health Sciences · other
Contacts & investigators
ContactSkaidrius Miliauskas, PhD, Prof. · contact · skaidrius.miliauskas@lsmu.lt · +37037326269
ContactIeva Dimiene, MD · contact · ieva.dimiene@lsmu.lt · +3737326953
InvestigatorSkaidrius Miliauskas, PhD, Prof. · principal_investigator, Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
All locations (1)
Lithuanian University of Health SciencesRecruiting
Kaunas, Kaunas County, Lithuania