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Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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: - Ganzkörperplethysmographie (GKP) - Diffusionskapazitätsmessung, Single-Breath (DLCO-SB)
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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06179342
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wissenschaftliches Institut Bethanien e.V
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lars Hagmeyer, PD Dr.
Principal Investigator Affiliation	Wissenschaftliches Institut Bethanien e.V
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis, COPD, Asthma

Additional Details

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.

Arms & Interventions

Arms

: Cardiopulmonary healthy

Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics

: Idiopathic pulmonary fibrosis

idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines

: Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) with/without emphysema

: Asthma bronchiale

Interventions

Diagnostic Test: - Multiple-Breath-Washout

One additional diagnostic test is performed using the Multiple-Breath-Washout technology

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.