Chronic Obstructive Pulmonary Disease ModerateNCT06072690
Respiratory and Cardiovascular Alterations in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease Moderate and Chronic Obstructive Pulmonary Disease Severe, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Moderate, Chronic Obstructive Pulmonary Disease Severe, Cardiovascular Diseases
- How many people
- 80 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Apr 2021to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, Kaunas County, 44307
Rimantas Benetis, PhD, Prof., +37037327200, rektoratas@lsmuni.lt
About this study
Official title: The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease
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
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline to 12 weeks
Secondary outcomes (19)
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
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on forced residual capacity to total lung capacity ratio (FRC/TLC) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Measured: Baseline to 12 weeks
Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Measured: Baseline to 12 weeks
Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on the structure of segmental bronchi measured in CT scan in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Measured: Baseline to 12 weeks
Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on right ventricle end-systolic volume index (RVESVi) in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on right ventricle end-diastolic volume index (RVEDVi) in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in right ventricular strain after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on right ventricular (RV) strain in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Measured: Baseline to 12 weeks
Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on left ventricle end-systolic volume index (LVESVi) in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on left ventricle end-diastolic volume index (LVEDVi) in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in stroke volume index after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on stroke volume index (SVi) in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in washout rate after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on washout rate (WR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in heart to mediastinum ratio after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on early and late heart to mediastinum ratio (HMR) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Change in left ventricle total defect score after 12 weeks of dual bronchodilation
The effect of dual bronchodilation on early and late left ventricle early total defect score (TDS) in cardiac sympathetic imaging with meta-iodobenzylguanidine in patients with newly diagnosed moderate-to-severe COPD
Measured: Baseline to 12 weeks
Differences in health-related quality of life between COPD and non-COPD individuals
Measured: Baseline
Differences in exercise capacity between COPD and non-COPD individuals
Measured: Baseline
Differences in right ventricular (RV) measurements between COPD and non-COPD individuals
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Apr 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Skaidrius Miliauskas, Lithuanian University of Health Sciences
- Investigators
- Skaidrius Miliauskas, PhD, Prof., Principal investigator, Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072690
- Sponsor's protocol ID
- COPDCVS1
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dimiene I, Neverauskaite-Piliponiene G, Bucius P, Simkus P, Padervinskiene L, Rimkunas A, Ereminiene E, Miliauskas S. Effects of dual bronchodilation on right ventricular function and troponin-I in newly diagnosed, moderate-to-severe chronic obstructive pulmonary disease: a prospective real-world observational study. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261452491. doi: 10.1177/17534666261452491. Epub 2026 Jun 24.
PubMed 42339592
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06072690
- Acronym / sponsor ID
- COPDCVS1
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- Active lung infection
- Present or previously treated lung cancer
- Alpha-1 antitrypsin deficiency
- Diagnosed interstitial lung disease
- Previously diagnosed asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
The effect of dual bronchodilation on peak oxygen uptake (VO2) in patients with newly diagnosed moderate-to-severe chronic obstructive pulmonary disease
Change in health-related quality of life after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
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
19 secondary outcomes
Change in forced expiratory volume in 1 second after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in forced vital capacity after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in residual volume after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in residual volume to total lung capacity ratio after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in forced residual capacity to total lung capacity ratio after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in diffusing capacity of the lungs for carbon monoxide after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Changes in the inner area of segmental bronchi after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in right ventricle end-systolic volume index after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in right ventricle end-diastolic volume index after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in right ventricular strain after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in left ventricle end-systolic volume index after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in left ventricle end-diastolic volume index after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in stroke volume index after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in washout rate after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in heart to mediastinum ratio after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Change in left ventricle total defect score after 12 weeks of dual bronchodilation
Time frame: Baseline to 12 weeks
Differences in health-related quality of life between COPD and non-COPD individuals
Time frame: Baseline
Differences in exercise capacity between COPD and non-COPD individuals
Time frame: Baseline
Differences in right ventricular (RV) measurements between COPD and non-COPD individuals
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Derived from this study: PubMed 42339592Dimiene I, Neverauskaite-Piliponiene G, Bucius P, Simkus P, Padervinskiene L, Rimkunas A, Ereminiene E, Miliauskas S. Effects of dual bronchodilation on right ventricular function and troponin-I in newly diagnosed, moderate-to-severe chronic obstructive pulmonary disease: a prospective real-world observational study. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261452491. doi: 10.1177/17534666261452491. Epub 2026 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Skaidrius Miliauskas, PhD, Prof. principal investigator
Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease Moderate and Chronic Obstructive Pulmonary Disease Severe, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Skaidrius Miliauskas, PhD, Prof. (+37037326269, skaidrius.miliauskas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxygen uptake at peak exercise after 12 weeks of dual bronchodilation (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.