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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (1)

Lithuanian University of Health Sciences
Kaunas, Kaunas County, Lithuania