COPD (Chronic Obstructive Pulmonary Disease)COPD-TBVNCT07428785
Pulmonary and Total Blood Volume in COPD
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Healthy Subjects, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Healthy Subjects
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2025to 20 Dec 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sjælland, Denmark
Who may be able to join
- Men and women
- 45-80 years
- COPD (GOLD stage I to III)
- Resting arterial oxygenation > 90% Inclusion criteria - controls
- Men and women
- 45-80 years
Show all 9Show fewer
- Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
- Same sex, age (± 3 years) and height (± 5 cm) as an included COPD patient
- Low- to moderate activity level defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)
Who cannot join
- Symptoms of ischaemic heart disease
- Known heart failure
- Previous severe or current COVID-19
- Claudication
- Symptoms of disease within 2 weeks prior to the study
- Participation in pulmonary rehabilitation within 6 months
Show all 20Show fewer
- Known malignant disease
- Pregnancy
- Unstable cardiac arrhythmic disease
- Renal or liver dysfunction
- Known chronic lung disease
- Known ischaemic heart disease
- Known heart failure
- Previous severe or current COVID-19
- Symptoms of disease within 2 weeks prior to the study
- Known malignant disease
- Claudication
- Pregnancy
- Unstable cardiac arrhythmic disease
- Renal or liver dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Aktiv Sundhed
Copenhagen, 2100
About this study
Official title: Pulmonary and Total Blood Volume in COPD: A Prosoective Matched Comparative Study
Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. In the present study, we aim to investigate whether this may involve a reduced pulmonary blood volume secondarily to a reduced total blood volume.
Methods Design: Prospective matched comparative study Intervention: None
Read more
Outcomes:
The primary outcome is pulmonary blood volume estimated to total blood volume ratio between patients with COPD and healthy controls individually matched for age, sex, and height.
Statistical design:
All statistical analyses will be performed using R statistical software version 4.1.1 (R Project for Statistical Computing) within RStudio statistical software version 1.4.1717 (RStudio), and a two-tailed p<0.05 will be considered statistically significant. Inspection of normality and variance homogeneity will be done by creating qq-plots and histogram.
Regulatory considerations: This study will be submitted for approval by Regional Ethical Committee.
Perspective: This study will help uncover fundamental aspects of the pathophysiology of COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Pulmonary rehabilitation is a cornerstone in the management of COPD and it is considered the most effective non-pharmacological intervention for improving quality of life. However, its wider use is limited by an incomplete understanding of the mechanisms underlying exercise-induced improvements in COPD. Exercise training is generally thought to exert little effect on lung function, at least when assessed by dynamic spirometry or diffusion capacity measured at rest in the upright position. Rehabilitation is mainly considered a mean to alleviate symptoms, primarily by improving skeletal muscle function, but without the potential to reverse any structural changes within the pulmonary system, which are seen in patients with COPD. The rationale for recommending exercise as a way to reduce symptom burden and increase quality of life, is based on the finding from the most recent Cochrane review.
An early feature of COPD is pulmonary vascular dysfunction, characterized by loss of pulmonary capillaries driven by a disease-specific imbalance between angiogenic and angiostatic processes. Indeed, this is likely a mechanism that drives the progressive loss of lung tissue, and also limits exercise capacity as the ability to expand the alveolar-capillary membrane though pulmonary capillary recruitment and distension becomes limited, thereby critically attenuating oxygen uptake during exercise. These pulmonary vascular abnormalities lead to a reduction in pulmonary blood volume (PBV), a phenomenon particularly evident in the supine position, where blood is mobilised from the lower extremities and abdomen to the pulmonary circulation, thus recruiting and distending the available pulmonary capillaries. Using 82Rb-PET, we recently demonstrated that PBV is markedly reduced in patients with COPD. However, it remains to be established whether this reduction reflects pulmonary vascular dysfunction or is simply secondary to systemic hypovolaemia, as total blood volume (TBV) has not yet been characterized in this population.
In the present study, we therefore aim to compare TBV and PBV in patients with COPD to those of age-, sex, and height-matched healthy controls.
Objectives:
Primary objective: To investigate whether patients with COPD exhibit systemic hypovolaemia.
Secondary objectives: To investigate whether the COPD-associated reduction in PBV is caused by a reduced TBV and the extent to which this limits exercise capacity.
Research hypotheses:
Primary: Patients with COPD exhibit a lower PBV/TBV-ratio than healthy individuals.
Secondary: Patients with COPD exhibit both a lower pulmonary capillary blood volume (VC), PBV, and TBV, exercise capacity, and rest-to-exercise increase in pulmonary diffusing capacity than healthy individuals.
- Keywords
- TBV, PBV, COPD, Pulmonary blood volume, Total blood volume
- Medical subject headings
- 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 |
|---|---|---|
| Healthy controls | healthy matched controls by sex, age, height to the COPD group | |
| Chronic obstructive pulmonary disease (COPD) | patients with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio)
Measured: day 2
Secondary outcomes (7)
pulmonary capillary blood volume/pulmonary blood volume ratio (VC/PBV-ratio)
Measured: day 2
Between-group difference in total blood volume (TBV)
Measured: day 2
Between-group difference in Pulmonary blood volume (PBV)
Measured: day 2
Between-group difference in total red blood cell volume
Measured: day 2
Between-group difference in total plasma volume
Measured: day 2
Between-group difference in the pulmonary diffusing capacity to (nitric oxide) DL,NO (mmol/(min kPa)) at 60% of maximal workload
Measured: day 2
Between-group difference in the pulmonary diffusing capacity to (nitric oxide) DL,NO (mmol/(min kPa)) at 50W
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start15 Sep 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ronan MG Berg, MD, DMSc, Study director, Center for Aktiv Sundhed, rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428785
- Sponsor's protocol ID
- H-25045320
- Acronym
- COPD-TBV
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Total Blood Volume in COPD: A Prosoective Matched Comparative Study
- ClinicalTrials.gov ID
- NCT07428785
- Acronym / sponsor ID
- COPD-TBV / H-25045320
- Keywords
- TBV, PBV, COPD, Pulmonary blood volume, Total blood volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (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.
Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. In the present study, we aim to investigate whether this may involve a reduced pulmonary blood volume secondarily to a reduced total blood volume.
Methods Design: Prospective matched comparative study Intervention: None
Outcomes:
The primary outcome is pulmonary blood volume estimated to total blood volume ratio between patients with COPD and healthy controls individually matched for age, sex, and height.
Statistical design:
All statistical analyses will be performed using R statistical software version 4.1.1 (R Project for Statistical Computing) within RStudio statistical software version 1.4.1717 (RStudio), and a two-tailed p<0.05 will be considered statistically significant. Inspection of normality and variance homogeneity will be done by creating qq-plots and histogram.
Regulatory considerations: This study will be submitted for approval by Regional Ethical Committee.
Perspective: This study will help uncover fundamental aspects of the pathophysiology of COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Pulmonary rehabilitation is a cornerstone in the management of COPD and it is considered the most effective non-pharmacological intervention for improving quality of life. However, its wider use is limited by an incomplete understanding of the mechanisms underlying exercise-induced improvements in COPD. Exercise training is generally thought to exert little effect on lung function, at least when assessed by dynamic spirometry or diffusion capacity measured at rest in the upright position. Rehabilitation is mainly considered a mean to alleviate symptoms, primarily by improving skeletal muscle function, but without the potential to reverse any structural changes within the pulmonary system, which are seen in patients with COPD. The rationale for recommending exercise as a way to reduce symptom burden and increase quality of life, is based on the finding from the most recent Cochrane review.
An early feature of COPD is pulmonary vascular dysfunction, characterized by loss of pulmonary capillaries driven by a disease-specific imbalance between angiogenic and angiostatic processes. Indeed, this is likely a mechanism that drives the progressive loss of lung tissue, and also limits exercise capacity as the ability to expand the alveolar-capillary membrane though pulmonary capillary recruitment and distension becomes limited, thereby critically attenuating oxygen uptake during exercise. These pulmonary vascular abnormalities lead to a reduction in pulmonary blood volume (PBV), a phenomenon particularly evident in the supine position, where blood is mobilised from the lower extremities and abdomen to the pulmonary circulation, thus recruiting and distending the available pulmonary capillaries. Using 82Rb-PET, we recently demonstrated that PBV is markedly reduced in patients with COPD. However, it remains to be established whether this reduction reflects pulmonary vascular dysfunction or is simply secondary to systemic hypovolaemia, as total blood volume (TBV) has not yet been characterized in this population.
In the present study, we therefore aim to compare TBV and PBV in patients with COPD to those of age-, sex, and height-matched healthy controls.
Objectives:
Primary objective: To investigate whether patients with COPD exhibit systemic hypovolaemia.
Secondary objectives: To investigate whether the COPD-associated reduction in PBV is caused by a reduced TBV and the extent to which this limits exercise capacity.
Research hypotheses:
Primary: Patients with COPD exhibit a lower PBV/TBV-ratio than healthy individuals.
Secondary: Patients with COPD exhibit both a lower pulmonary capillary blood volume (VC), PBV, and TBV, exercise capacity, and rest-to-exercise increase in pulmonary diffusing capacity than healthy individuals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –healthy matched controls by sex, age, height to the COPD group |
| Chronic obstructive pulmonary disease (COPD) | – | –patients with COPD |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sjælland, Denmark
Key inclusion criteria (9 listed)
Key exclusion criteria (20 listed)
- Symptoms of ischaemic heart disease
- Known heart failure
- Previous severe or current COVID-19
- Claudication
- Symptoms of disease within 2 weeks prior to the study
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
Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio)
Time frame: day 2
7 secondary outcomes
pulmonary capillary blood volume/pulmonary blood volume ratio (VC/PBV-ratio)
Time frame: day 2
Between-group difference in total blood volume (TBV)
Time frame: day 2
Between-group difference in Pulmonary blood volume (PBV)
Time frame: day 2
Between-group difference in total red blood cell volume
Time frame: day 2
Between-group difference in total plasma volume
Time frame: day 2
Between-group difference in the pulmonary diffusing capacity to (nitric oxide) DL,NO (mmol/(min kPa)) at 60% of maximal workload
Time frame: day 2
Between-group difference in the pulmonary diffusing capacity to (nitric oxide) DL,NO (mmol/(min kPa)) at 50W
Time frame: day 2
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ronan MG Berg, MD, DMSc study director
Center for Aktiv Sundhed, rigshospitalet
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 COPD (Chronic Obstructive Pulmonary Disease) and Healthy Subjects, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 inclusion and 20 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 Oct 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 Denmark. 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 Ronan MG Berg, MD, DMSc (004535451825, ronan@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio) (time frame: day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.