Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorLithuanian University of Health Sciences

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Active lung infection

Present or previously treated lung cancer

Alpha-1 antitrypsin deficiency

Diagnosed interstitial lung disease

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: COPD group
Group B: Non-COPD group

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 12 weeks
2

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

Time frame
Baseline to 12 weeks

Secondary outcomes

1

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

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

Time frame
Baseline to 12 weeks
2

Change in forced vital capacity after 12 weeks of dual bronchodilation

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

Time frame
Baseline to 12 weeks
3

Change in residual volume after 12 weeks of dual bronchodilation

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

Time frame
Baseline to 12 weeks
4

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

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

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

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