COPDNCT05092035
Recognition of Early Pulmonary Structural Changes by Using Real-time High Fidelity Expiratory CO2 Analysis
A study testing single high-fidelity expiratory CO2 analysis in people with COPD and ILD, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this study the investigators aim to detect and characterize structural airway and lung vessel changes due to COPD or ILD as assessed by real-time high fidelity expiratory CO2 analysis. The long-term goal is to detect pulmonary structural changes in a stage, when variables of currently used standard methods (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- single high-fidelity expiratory CO2 analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2020to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all male and female patients older than 18 years who have COPD, ILD or are smokers and non smokers without pulmonary diseases.
- right heart catheterization performed due to to suspected pulmonary hypertension and further clinical investigation like echocardiography, lung function testing, 6-minute walk test, laboratory testing and blood gas analysis.
- written informed consent
Who cannot join
- contraindication for lung function testing
- acute life-threatening disease (including acute myocardiac infarction, pulmonary embolism, large aortic aneurysma, pneumothorax, opthalmic, brain, abdominal or thoracic surgery within the last 4 weeks, hemoptysis).
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators aim to detect and characterize structural airway and lung vessel changes due to COPD or ILD as assessed by real-time high fidelity expiratory CO2 analysis. The long-term goal is to detect pulmonary structural changes in a stage, when variables of currently used standard methods (e.g. pulmonary function test) are not yet altered.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide and is responsible for over 6% of all-cause mortality. Due to aging societies and exposure to risk factors, increasing prevalence is expected in the following years. Cigarette smoking is the most important risk factor for COPD, but also non-smokers may develop the disease. Although COPD is primarily seen as obstructive airway disease, it may also affect the lung parenchyma, the lung vessels, the systemic vessels, the heart and other organs. Therefore, COPD may be seen as a "pulmonary component of a systemic disease ". According to recent evidence patients with COPD and relevant lung vessel disease are at a higher risk to develop exacerbations and have worse prognosis. Usually, COPD patients suffer from a mild pulmonary hypertension, however some of them may present with a "pulmonal vascular phenotype" (PVP). Patients with PVP usually suffer from a relatively mild airway obstruction and are characterized by pathological changes in the small lung vessels, strongly elevated pulmonary vascular resistance, severely reduced diffusion capacity, normo- or hypocapnia, circulatory limitation of exercise capacity and a progressive right heart failure. Early recognition and therapy of COPD may stop further progression of the disease and the development of complications including changes in the small lung vessel.
Interstitial lung diseases (ILD) are characterized by structural changes in the lungs with fibrotic destruction and loss of alveolar tissue. Male gender and smoke exposure are frequent risk factors. At the time of diagnosis, patients are usually in an impaired physical condition suffering from severe symptoms and advanced functional limitation. In a subgroup of patients, a severe lung vessel disease is present further worsening prognosis. Although in the past few years major improvements in the therapy of some forms of ILD have been achieved, the available drugs are not curative. Their aim remains to slow down disease progression. Therefore, an early detection of ILDs may help to initiate targeted treatment on time and improve the prognosis of patients.
Structural pulmonary changes both due to COPD or ILD result in a loss of small airways and small lung vessels, which are not detectable with standard pulmonary function tests until 50% of the small airways disappeared. Although these changes may also take place due to physiological lung-aging, in smokers this effect is clearly accelerated. Diffusion capacity (DLCO) and the so-called Krogh factor (KCO) are sensible markers of early pulmonary structural changes. In addition, lung density as assessed by high-resolution CT-scan and analyzed by specific software represents a sensitive tool. Pulmonary vascular resistance (PVR) and pulmonary vascular compliance are sensitive parameters for the detection of pulmonary vascular changes.
Similar to DLCO, high fidelity analysis of expiratory CO2-flow measurement may allow a sensitive detection of structural pulmonary changes. The method has the advantage that no extrinsic gas is needed. The aim of this explorative pilot study is to investigate if high fidelity expiratory CO2-analysis is able to detect early pulmonary structural changes, even before it can be assessed by pulmonary function testing (e.g. FEV1 or vital capacity).
- Being tested
- single high-fidelity expiratory CO2 analysis
- Keywords
- structural pulmonary changes, High fidelity analysis of expiratory CO2 flow
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single high-fidelity expiratory CO2 analysisDiagnostic test
in addition to regular pulmonary function testing a real-time high-fidelity assessment of expiratory CO2 will be performed
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Other | COPD patients Receives: Diagnostic Test: single high-fidelity expiratory CO2 analysis |
| ILD patients | Other | ILD patients Receives: Diagnostic Test: single high-fidelity expiratory CO2 analysis |
| non-smoker controls | Other | non-smoker controls Receives: Diagnostic Test: single high-fidelity expiratory CO2 analysis |
| smoker controls | Other | smoker controls Receives: Diagnostic Test: single high-fidelity expiratory CO2 analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in partial pressure of CO2 (in mmHg) during expiration
the change in real-time high-fidelity partial pressures of CO2 (in mmHg) during expiration will be compared among groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Mar 2020
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 Groups, two control Groups (smokers and non-smokers), one COPD group, one ILD group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, Prof., Principal investigator, Devision of Pulmonology, Medical University Hospital of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092035
- Sponsor's protocol ID
- ID 7684
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.
PubMed 30846476Tanabe N, Vasilescu DM, McDonough JE, Kinose D, Suzuki M, Cooper JD, Pare PD, Hogg JC. Micro-Computed Tomography Comparison of Preterminal Bronchioles in Centrilobular and Panlobular Emphysema. Am J Respir Crit Care Med. 2017 Mar 1;195(5):630-638. doi: 10.1164/rccm.201602-0278OC.
PubMed 27611890McDonough JE, Yuan R, Suzuki M, Seyednejad N, Elliott WM, Sanchez PG, Wright AC, Gefter WB, Litzky L, Coxson HO, Pare PD, Sin DD, Pierce RA, Woods JC, McWilliams AM, Mayo JR, Lam SC, Cooper JD, Hogg JC. Small-airway obstruction and emphysema in chronic obstructive pulmonary disease. N Engl J Med. 2011 Oct 27;365(17):1567-75. doi: 10.1056/NEJMoa1106955.
PubMed 22029978Nathan SD, Barbera JA, Gaine SP, Harari S, Martinez FJ, Olschewski H, Olsson KM, Peacock AJ, Pepke-Zaba J, Provencher S, Weissmann N, Seeger W. Pulmonary hypertension in chronic lung disease and hypoxia. Eur Respir J. 2019 Jan 24;53(1):1801914. doi: 10.1183/13993003.01914-2018. Print 2019 Jan.
PubMed 30545980Kovacs G, Agusti A, Barbera JA, Celli B, Criner G, Humbert M, Sin DD, Voelkel N, Olschewski H. Pulmonary Vascular Involvement in Chronic Obstructive Pulmonary Disease. Is There a Pulmonary Vascular Phenotype? Am J Respir Crit Care Med. 2018 Oct 15;198(8):1000-1011. doi: 10.1164/rccm.201801-0095PP. No abstract available.
PubMed 29746142
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition of Early Pulmonary Structural Changes by Using Real-time High Fidelity Expiratory CO2 Analysis
- ClinicalTrials.gov ID
- NCT05092035
- Acronym / sponsor ID
- ID 7684
- Keywords
- structural pulmonary changes, High fidelity analysis of expiratory CO2 flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators aim to detect and characterize structural airway and lung vessel changes due to COPD or ILD as assessed by real-time high fidelity expiratory CO2 analysis. The long-term goal is to detect pulmonary structural changes in a stage, when variables of currently used standard methods (e.g. pulmonary function test) are not yet altered.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide and is responsible for over 6% of all-cause mortality. Due to aging societies and exposure to risk factors, increasing prevalence is expected in the following years. Cigarette smoking is the most important risk factor for COPD, but also non-smokers may develop the disease. Although COPD is primarily seen as obstructive airway disease, it may also affect the lung parenchyma, the lung vessels, the systemic vessels, the heart and other organs. Therefore, COPD may be seen as a "pulmonary component of a systemic disease ". According to recent evidence patients with COPD and relevant lung vessel disease are at a higher risk to develop exacerbations and have worse prognosis. Usually, COPD patients suffer from a mild pulmonary hypertension, however some of them may present with a "pulmonal vascular phenotype" (PVP). Patients with PVP usually suffer from a relatively mild airway obstruction and are characterized by pathological changes in the small lung vessels, strongly elevated pulmonary vascular resistance, severely reduced diffusion capacity, normo- or hypocapnia, circulatory limitation of exercise capacity and a progressive right heart failure. Early recognition and therapy of COPD may stop further progression of the disease and the development of complications including changes in the small lung vessel.
Interstitial lung diseases (ILD) are characterized by structural changes in the lungs with fibrotic destruction and loss of alveolar tissue. Male gender and smoke exposure are frequent risk factors. At the time of diagnosis, patients are usually in an impaired physical condition suffering from severe symptoms and advanced functional limitation. In a subgroup of patients, a severe lung vessel disease is present further worsening prognosis. Although in the past few years major improvements in the therapy of some forms of ILD have been achieved, the available drugs are not curative. Their aim remains to slow down disease progression. Therefore, an early detection of ILDs may help to initiate targeted treatment on time and improve the prognosis of patients.
Structural pulmonary changes both due to COPD or ILD result in a loss of small airways and small lung vessels, which are not detectable with standard pulmonary function tests until 50% of the small airways disappeared. Although these changes may also take place due to physiological lung-aging, in smokers this effect is clearly accelerated. Diffusion capacity (DLCO) and the so-called Krogh factor (KCO) are sensible markers of early pulmonary structural changes. In addition, lung density as assessed by high-resolution CT-scan and analyzed by specific software represents a sensitive tool. Pulmonary vascular resistance (PVR) and pulmonary vascular compliance are sensitive parameters for the detection of pulmonary vascular changes.
Similar to DLCO, high fidelity analysis of expiratory CO2-flow measurement may allow a sensitive detection of structural pulmonary changes. The method has the advantage that no extrinsic gas is needed. The aim of this explorative pilot study is to investigate if high fidelity expiratory CO2-analysis is able to detect early pulmonary structural changes, even before it can be assessed by pulmonary function testing (e.g. FEV1 or vital capacity).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 3 Groups, two control Groups (smokers and non-smokers), one COPD group, one ILD group
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Other | Diagnostic Test: single high-fidelity expiratory CO2 analysisCOPD patients |
| ILD patients | Other | Diagnostic Test: single high-fidelity expiratory CO2 analysisILD patients |
| non-smoker controls | Other | Diagnostic Test: single high-fidelity expiratory CO2 analysisnon-smoker controls |
| smoker controls | Other | Diagnostic Test: single high-fidelity expiratory CO2 analysissmoker controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all male and female patients older than 18 years who have COPD, ILD or are smokers and non smokers without pulmonary diseases.
- right heart catheterization performed due to to suspected pulmonary hypertension and further clinical investigation like echocardiography, lung function testing, 6-minute walk test, laboratory testing and blood gas analysis.
- written informed consent
Key exclusion criteria (2 listed)
- contraindication for lung function testing
- acute life-threatening disease (including acute myocardiac infarction, pulmonary embolism, large aortic aneurysma, pneumothorax, opthalmic, brain, abdominal or thoracic surgery within the last 4 weeks, hemoptysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single high-fidelity expiratory CO2 analysisin addition to regular pulmonary function testing a real-time high-fidelity assessment of expiratory CO2 will be performed | Diagnostic test | COPD patients, ILD patients, non-smoker controls, smoker controls |
Primary outcome
change in partial pressure of CO2 (in mmHg) during expiration
Time frame: 1 day
the change in real-time high-fidelity partial pressures of CO2 (in mmHg) during expiration will be compared among groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 30846476Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.
- Results publication: PubMed 27611890Tanabe N, Vasilescu DM, McDonough JE, Kinose D, Suzuki M, Cooper JD, Pare PD, Hogg JC. Micro-Computed Tomography Comparison of Preterminal Bronchioles in Centrilobular and Panlobular Emphysema. Am J Respir Crit Care Med. 2017 Mar 1;195(5):630-638. doi: 10.1164/rccm.201602-0278OC.
- Results publication: PubMed 22029978McDonough JE, Yuan R, Suzuki M, Seyednejad N, Elliott WM, Sanchez PG, Wright AC, Gefter WB, Litzky L, Coxson HO, Pare PD, Sin DD, Pierce RA, Woods JC, McWilliams AM, Mayo JR, Lam SC, Cooper JD, Hogg JC. Small-airway obstruction and emphysema in chronic obstructive pulmonary disease. N Engl J Med. 2011 Oct 27;365(17):1567-75. doi: 10.1056/NEJMoa1106955.
- Results publication: PubMed 30545980Nathan SD, Barbera JA, Gaine SP, Harari S, Martinez FJ, Olschewski H, Olsson KM, Peacock AJ, Pepke-Zaba J, Provencher S, Weissmann N, Seeger W. Pulmonary hypertension in chronic lung disease and hypoxia. Eur Respir J. 2019 Jan 24;53(1):1801914. doi: 10.1183/13993003.01914-2018. Print 2019 Jan.
- Results publication: PubMed 29746142Kovacs G, Agusti A, Barbera JA, Celli B, Criner G, Humbert M, Sin DD, Voelkel N, Olschewski H. Pulmonary Vascular Involvement in Chronic Obstructive Pulmonary Disease. Is There a Pulmonary Vascular Phenotype? Am J Respir Crit Care Med. 2018 Oct 15;198(8):1000-1011. doi: 10.1164/rccm.201801-0095PP. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Olschewski, Prof. principal investigator
Devision of Pulmonology, Medical University Hospital of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single high-fidelity expiratory CO2 analysis in people with COPD and ILD, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in partial pressure of CO2 (in mmHg) during expiration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05092035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.