Clinical trial NCT06287476: Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA)
Official title: Alveolar-capillary Reserve After Exercise in COPD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Alveolar-capillary membrane integrity
Lung tissue mass
Cardiac Output
DLCO/DLNO
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls
timeFrame: Measured at study day 2
Secondary outcomes:
measure: Pulmonary DTPA clearance at rest in COPD vs. controls
timeFrame: Measured at study day 2
measure: Pulmonary DTPA clearance after exercise in COPD vs. controls
timeFrame: Measured at study day 2
measure: Rest-to-exercise change in lung tissue mass in COPD vs. controls
timeFrame: Measured at study day 2
Other outcomes:
measure: Lung tissue mass at rest in COPD vs. controls
timeFrame: Measured at study day 2
measure: Lung tissue mass after exercise in COPD vs. controls
timeFrame: Measured at study day 2
measure: Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD
timeFrame: Measured at study day 2
measure: Supine pulmonary capillary blood volume after exercise in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine cardiac output after exercise in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine pulmonary capillary blood volume at rest in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine cardiac output at rest in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls
timeFrame: Measured at study day 3
measure: Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls
timeFrame: Measured at study day 3
Locations:
city: Copenhagen
country: Denmark
facility: Center For Physical Activity Research, Rigshospitalet
Study officials:
References: