Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Comparison of New Methods of Multiple Breath Washout and Diffusion Capacity Determination (Ndd Medizintechnik Zurich, Trueflow™/Truecheck™) With Established Methods of Lung Function Diagnostics in Patients With Idiopathic Pulmonary Fibrosis, Chronic Obstructive Pulmonary Disease, Asthma and Cardiopulmonary Healthy Individuals

Comparison of the new multiple-breath washout method (ndd Medizintechnik Zürich, Trueflow™/Truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.

Study Overview

• Status: Completed
• Conditions: Asthma; Pulmonary Fibrosis; COPD
• Intervention / Treatment: Diagnostic test: Multiple-Breath-Washout

Detailed Description

This diagnostic, prospective, clinical study aims to investigate whether the lung function data measured with the EasyOnePro®LAB device correlates with the lung function data from established measurement methods used in routine clinical practice. It is to be investigated whether the EasyOnePro®LAB measurement leads to equivalent results even with a shorter measurement duration due to an improved evaluation. This is relevant for a broader clinical application in the future.

It will also be tested whether the fact that the EasyOnePro®LAB measurement can be carried out largely independently of the employee also leads to better reproducibility of the results. To this end, the intra-individual deviations in repeated measurements will be compared between the methods.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Solingen, NRW, Germany, 42699
      • Wissenschaftliches Institut Bethanien e.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to the study center with one of the above-mentioned diseases

Description

Inclusion Criteria:

• Age ≥ 18 years
• existing consent
• confirmed diagnosis of one of the following diseases
• idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines
• chronic obstructive pulmonary disease (COPD) with/without emphysema
• bronchial asthma
• or patients who are admitted with suspected cardiopulmonary dysfunction (e.g. with unclear dyspnoea) and in whom there is no evidence of cardiopulmonary dysfunction during the diagnostic process (comparison group of "healthy" patients).
• Indication for routine performance of the following pulmonary function tests during the current inpatient stay: Whole Body Plethysmography & Diffusion Capacity of the Lung (single-breath)

Exclusion Criteria:

• Age < 18 years
• Simultaneous presence of at least two of the following diseases (IPF, COPD/emphysema, asthma, pulmonary arterial hypertension)
• any medical, psychological or other condition that restricts the patient's ability to give informed consent for voluntary participation in this trial

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiopulmonary healthy; Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics	Diagnostic test: Multiple-Breath-Washout; One additional diagnostic test is performed using the Multiple-Breath-Washout technology
Idiopathic pulmonary fibrosis; idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines	Diagnostic test: Multiple-Breath-Washout; One additional diagnostic test is performed using the Multiple-Breath-Washout technology
Chronic obstructive pulmonary disease; Chronic obstructive pulmonary disease (COPD) with/without emphysema	Diagnostic test: Multiple-Breath-Washout; One additional diagnostic test is performed using the Multiple-Breath-Washout technology
Asthma bronchiale	Diagnostic test: Multiple-Breath-Washout; One additional diagnostic test is performed using the Multiple-Breath-Washout technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Clearance Index	comparison of the lung clearance index of the different patient groups	immediately ofter the procedure

Collaborators and Investigators

• Sponsor: Wissenschaftliches Institut Bethanien e.V
• Collaborators: Boehringer Ingelheim; ndd Medizintechnik AG
• Investigators: Principal Investigator: Lars Hagmeyer, PD Dr., Wissenschaftliches Institut Bethanien e.V

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases, Interstitial; Fibrosis; Asthma; Pulmonary Fibrosis
• Other Study ID Numbers: WI_20-1542_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No