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

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: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Acute exercise bout on visit 2 and 3

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: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary DTPA clearance at rest in COPD vs. controls	Pulmonary DTPA clearance measured by pulmonary DTPA clearance at rest	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 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 at study day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Supine cardiac output after exercise in COPD vs. controls	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	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	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	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	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	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	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	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	DM after exercise obtained by combined DLCO/NO technique with 5-sec breath-hold	Measured at study day 3

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Cardiac Output; Lung tissue mass; Alveolar-capillary membrane integrity; DLCO/DLNO
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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