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Completed

NCT Number: NCT06287476

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center For Physical Activity Research, Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acute exercise bout on visit 2 and 3

Other
  • 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  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

  3. 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

Other outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Alveolar-capillary Reserve After Exercise in COPD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2024
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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