Chronic Obstructive Pulmonary DiseaseNCT06287476
Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)
A study testing Acute exercise bout on visit 2 and 3 in people with Chronic Obstructive Pulmonary Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Acute exercise bout on visit 2 and 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2024to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Men and women
- 45-80 years old
- COPD (GOLD stage I to III)
- Resting arterial oxygenation > 90%
- Men and women
- 45-80 years old
Show all 9Show fewer
- Non-smokers
- Normal lung function
- Same sex, age (± 3 years) as the COPD group
Who cannot join
- Symptoms of ischemic heart disease
- Known heart failure
- Symptoms of illness, including fever, within 2 weeks prior to the study
- Pregnancy
- • Known renal or liver diseaseActive smoking (within 3 weeks)
- Known chronic lung disease
Show all 12Show fewer
- Symptoms of ischemic heart disease
- Known heart failure
- Symptoms of illness, including fever, within 2 weeks prior to the study
- Pregnancy
- Known renal or liver disease
- Active smoking (within 3 weeks)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center For Physical Activity Research, Rigshospitalet
Copenhagen
About this study
Official title: Alveolar-capillary Reserve After Exercise in COPD
It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.
Read the detailed description
It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. The study participants include a control group and a group with COPD (GOLD I-III). Participants are undergoing three study days: (1) Measurement of maximal aerobic capacity and lung function test, (2) lung tissue mass and alveolar-capillary permeability is measured at rest and again 2 hours later, immediately after the participant has exercised on a bicycle ergometer and (3) supine cardiac output and pulmonary capillary blood volume will be measured at rest and immediately after exercise.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Acute exercise bout on visit 2 and 3
- Keywords
- COPD, Alveolar-capillary membrane integrity, Lung tissue mass, Cardiac Output, DLCO/DLNO
- 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.
Acute exercise bout on visit 2 and 3Other
- a 5-minute warm-up, 2) 4 minutes at 60% of the maximal workload (determined on Study Day 1), 3) 2 minutes active break at 15 watt, 4) 4 minutes at maximal workload.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | This arm consist of only healthy participants (age (+/- 3 years) and sex matched to the COPD group), which will undergo three study visits Receives: Other: Acute exercise bout on visit 2 and 3 |
| COPD group | Experimental | This arm consist of only COPD patients, which will undergo three study visits Receives: Other: Acute exercise bout on visit 2 and 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls
The physiological change from rest to exercise in DTPA clearance
Measured: Measured at study day 2
Secondary outcomes (3)
Pulmonary DTPA clearance at rest in COPD vs. controls
Pulmonary DTPA clearance measured by pulmonary DTPA clearance at rest
Measured: Measured at study day 2
Pulmonary DTPA clearance after exercise in COPD vs. controls
Pulmonary DTPA clearance measured by pulmonary DTPA clearance after exercise
Measured: Measured at study day 2
Rest-to-exercise change in lung tissue mass in COPD vs. controls
The physiological change from rest to exercise in lung tissue mass measured by low-dose CT-scan
Measured: Measured at study day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start6 May 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287476
- Sponsor's protocol ID
- H-23043870
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar-capillary Reserve After Exercise in COPD
- ClinicalTrials.gov ID
- NCT06287476
- Acronym / sponsor ID
- H-23043870
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Alveolar-capillary membrane integrity, Lung tissue mass, Cardiac Output, DLCO/DLNO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 1 Mar 2024 (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.
It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.
Detailed description
It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. The study participants include a control group and a group with COPD (GOLD I-III). Participants are undergoing three study days: (1) Measurement of maximal aerobic capacity and lung function test, (2) lung tissue mass and alveolar-capillary permeability is measured at rest and again 2 hours later, immediately after the participant has exercised on a bicycle ergometer and (3) supine cardiac output and pulmonary capillary blood volume will be measured at rest and immediately after exercise.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Acute exercise bout on visit 2 and 3This arm consist of only healthy participants (age (+/- 3 years) and sex matched to the COPD group), which will undergo three study visits |
| COPD group | Experimental | Other: Acute exercise bout on visit 2 and 3This arm consist of only COPD patients, which will undergo three study visits |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women
- 45-80 years old
- COPD (GOLD stage I to III)
- Resting arterial oxygenation > 90%
- Men and women
Key exclusion criteria (12 listed)
- Symptoms of ischemic heart disease
- Known heart failure
- Symptoms of illness, including fever, within 2 weeks prior to the study
- Pregnancy
- • Known renal or liver diseaseActive smoking (within 3 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute exercise bout on visit 2 and 31) a 5-minute warm-up, 2) 4 minutes at 60% of the maximal workload (determined on Study Day 1), 3) 2 minutes active break at 15 watt, 4) 4 minutes at maximal workload. | Other | COPD group, Control Group |
Primary outcome
Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls
Time frame: Measured at study day 2
The physiological change from rest to exercise in DTPA clearance
3 secondary outcomes
Pulmonary DTPA clearance at rest in COPD vs. controls
Time frame: Measured at study day 2
Pulmonary DTPA clearance after exercise in COPD vs. controls
Time frame: Measured at study day 2
Rest-to-exercise change in lung tissue mass in COPD vs. controls
Time frame: Measured at study day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute exercise bout on visit 2 and 3 in people with Chronic Obstructive Pulmonary Disease, 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 12 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: finished, as of the sponsor's last update on 8 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls (time frame: Measured at study 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 8 Dec 2025.