Recognition of Early Pulmonary Structural Changes by Using Real-time High Fidelity Expiratory CO2 Analysis

NCT05092035 | Completed

• 1 other identifier: ID 7684
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. pulmonary function test) are not yet altered.

Conditions

COPD; ILD

Keywords

structural pulmonary changes; High fidelity analysis of expiratory CO2 flow

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Study Arms (4)

COPD patients

OTHER

COPD patients

Diagnostic Test: single high-fidelity expiratory CO2 analysis

ILD patients

OTHER

ILD patients

Diagnostic Test: single high-fidelity expiratory CO2 analysis

non-smoker controls

OTHER

non-smoker controls

Diagnostic Test: single high-fidelity expiratory CO2 analysis

smoker controls

OTHER

smoker controls

Diagnostic Test: single high-fidelity expiratory CO2 analysis

Interventions

single high-fidelity expiratory CO2 analysis DIAGNOSTIC_TEST

in addition to regular pulmonary function testing a real-time high-fidelity assessment of expiratory CO2 will be performed

COPD patients; ILD patients; non-smoker controls; smoker controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Internal Medicine, Pulmonology

Graz, Styria, 8036, Austria

Location

Related Publications (5)

• 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.

  PMID: 30846476 RESULT

• Tanabe 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.

  PMID: 27611890 RESULT

• McDonough 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.

  PMID: 22029978 RESULT

• Nathan 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.

  PMID: 30545980 RESULT

• Kovacs 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.

  PMID: 29746142 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Horst Olschewski, Prof.

  Devision of Pulmonology, Medical University Hospital of Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 Groups, two control Groups (smokers and non-smokers), one COPD group, one ILD group

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: October 25, 2021
• Study Start: March 1, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

AU (1)