Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)

December 1, 2025 updated by: Ronan Berg, Rigshospitalet, Denmark

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ronan MG Berg, MD, DMSc
  • Phone Number: 004535451825
  • Email: ronan@sund.ku.dk

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Center For Physical Activity Research, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria - individuals with COPD

  • Men and women
  • 45-80 years old
  • COPD (GOLD stage I to III)
  • Resting arterial oxygenation > 90%

Inclusion criteria - healthy controls

  • Men and women
  • 45-80 years old
  • Non-smokers
  • Normal lung function
  • Same sex, age (± 3 years) as the COPD group

Exclusion criteria - individuals with COPD

  • 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)

Exclusion criteria - healthy controls

  • Known chronic lung disease
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control Group
This arm consist of only healthy participants (age (+/- 3 years) and sex matched to the COPD group), which will undergo three study visits
Other: Acute exercise bout on visit 2 and 3
1) 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.
Experimental: COPD group
This arm consist of only COPD patients, which will undergo three study visits
Other: Acute exercise bout on visit 2 and 3
1) 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured at study day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary DTPA clearance at rest in COPD vs. controls
Time Frame: Measured at study day 2
Pulmonary DTPA clearance measured by pulmonary DTPA clearance at rest
Measured at study day 2
Pulmonary DTPA clearance after exercise in COPD vs. controls
Time Frame: Measured at study day 2
Pulmonary DTPA clearance measured by pulmonary DTPA clearance after exercise
Measured at study day 2
Rest-to-exercise change in lung tissue mass in COPD vs. controls
Time Frame: Measured at study day 2
The physiological change from rest to exercise in lung tissue mass measured by low-dose CT-scan
Measured at study day 2

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lung tissue mass at rest in COPD vs. controls
Time Frame: Measured at study day 2
Lung tissue mass measured at rest by low-dose CT-scan
Measured at study day 2
Lung tissue mass after exercise in COPD vs. controls
Time Frame: Measured at study day 2
Lung tissue mass measured at exercise by low-dose CT-scan
Measured at study day 2
Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD
Time Frame: Measured at study day 2
The physiological change from rest to exercise in lung tissue mass measured by low-dose CT-scan and the physiological change from rest to exercise in DTPA clearance according to different GOLD stages
Measured at study day 2
Supine pulmonary capillary blood volume after exercise in COPD vs. controls
Time Frame: Measured at study day 3
Pulmonary capillary blood volume (VC) after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine cardiac output after exercise in COPD vs. controls
Time Frame: Measured at study day 3
Cardiac output measured after exercise by a Finometer device
Measured at study day 3
Supine pulmonary capillary blood volume at rest in COPD vs. controls
Time Frame: Measured at study day 3
VC at rest obtained by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine cardiac output at rest in COPD vs. controls
Time Frame: Measured at study day 3
Cardiac output measured at rest by a Finometer device
Measured at study day 3
Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls
Time Frame: Measured at study day 3
DLNO measured after exercise by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls
Time Frame: Measured at study day 3
DLCOc measured after exercise by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls
Time Frame: Measured at study day 3
Membrane diffusion capacity (DM) after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls
Time Frame: Measured at study day 3
DLNO measured at rest by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls
Time Frame: Measured at study day 3
DLCOc measured at rest by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3
Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls
Time Frame: Measured at study day 3
DM after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold
Measured at study day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-23043870

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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