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Multiple Breath Washout as a Method for Diagnosing Lung Diseases

W

Wissenschaftliches Institut Bethanien e.V

Status

Completed

Conditions

Pulmonary Fibrosis
Asthma
COPD

Treatments

Diagnostic Test: Multiple-Breath-Washout

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06179342
WI_20-1542_1

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

90 participants in 4 patient groups

Cardiopulmonary healthy
Description:
Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics
Treatment:
Diagnostic Test: Multiple-Breath-Washout
Idiopathic pulmonary fibrosis
Description:
idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines
Treatment:
Diagnostic Test: Multiple-Breath-Washout
Chronic obstructive pulmonary disease
Description:
Chronic obstructive pulmonary disease (COPD) with/without emphysema
Treatment:
Diagnostic Test: Multiple-Breath-Washout
Asthma bronchiale
Treatment:
Diagnostic Test: Multiple-Breath-Washout

Trial contacts and locations

1

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Central trial contact

Lars Hagmeyer, PD Dr.; Anika Hain

Data sourced from clinicaltrials.gov

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