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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Alveolar-capillary Reserve After Exercise in COPD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287476
• Other study ID #: H-23043870
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: Ronan MG Berg, MD, DMSc
• Phone: 004535451825
• Email: ronan[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Denmark	Center For Physical Activity Research, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung tissue mass at rest in COPD vs. controls	Lung tissue mass measured at rest by low-dose CT-scan	Measured at study day 2
Other	Lung tissue mass after exercise in COPD vs. controls	Lung tissue mass measured at exercise by low-dose CT-scan	Measured at study day 2
Other	Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD	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
Other	Supine pulmonary capillary blood volume after exercise in COPD vs. controls	Pulmonary capillary blood volume (VC) after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine cardiac output after exercise in COPD vs. controls	Cardiac output measured after exercise by a Finometer device	Measured at study day 3
Other	Supine pulmonary capillary blood volume at rest in COPD vs. controls	VC at rest obtained by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine cardiac output at rest in COPD vs. controls	Cardiac output measured at rest by a Finometer device	Measured at study day 3
Other	Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls	DLNO measured after exercise by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls	DLCOc measured after exercise by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls	Membrane diffusion capacity (DM) after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls	DLNO measured at rest by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls	DLCOc measured at rest by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Other	Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls	DM after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3
Primary	Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls	The physiological change from rest to exercise in DTPA clearance	Measured at study day 2
Secondary	Pulmonary DTPA clearance at rest in COPD vs. controls	Pulmonary DTPA clearance measured by pulmonary DTPA clearance at rest	Measured at study day 2
Secondary	Pulmonary DTPA clearance after exercise in COPD vs. controls	Pulmonary DTPA clearance measured by pulmonary DTPA clearance after exercise	Measured at study day 2
Secondary	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 at study day 2