Pulmonary FibrosisNCT06179342
Multiple Breath Washout as a Method for Diagnosing Lung Diseases
An observational study of Pulmonary Fibrosis and COPD, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Fibrosis, COPD, Asthma
- What is being tested?
- Multiple-Breath-Washout
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jun 2021to 1 Mar 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the study center with one of the above-mentioned diseases
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Wissenschaftliches Institut Bethanien e.V.
Solingen, North Rhine-Westphalia, 42699
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Fibrosis, COPD, Asthma
- Being tested
- Multiple-Breath-Washout
- Medical subject headings
- Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple-Breath-WashoutDiagnostic test
One additional diagnostic test is performed using the Multiple-Breath-Washout technology
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary healthy | Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics Receives: Diagnostic Test: Multiple-Breath-Washout | |
| Idiopathic pulmonary fibrosis | idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines Receives: Diagnostic Test: Multiple-Breath-Washout | |
| Chronic obstructive pulmonary disease | Chronic obstructive pulmonary disease (COPD) with/without emphysema Receives: Diagnostic Test: Multiple-Breath-Washout | |
| Asthma bronchiale | Not described Receives: Diagnostic Test: Multiple-Breath-Washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index
comparison of the lung clearance index of the different patient groups
Measured: immediately ofter the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start21 Jun 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, ndd Medizintechnik AG
- Responsible party
- Sponsor
- Investigators
- Lars Hagmeyer, PD Dr., Principal investigator, Wissenschaftliches Institut Bethanien e.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179342
- Sponsor's protocol ID
- WI_20-1542_1
- Status last verified
- May 2024
- First submitted
- 6 Dec 2023
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06179342
- Acronym / sponsor ID
- WI_20-1542_1
- Conditions
- Pulmonary Fibrosis, COPD, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, ndd Medizintechnik AG
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 21 Dec 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary healthy | – | Diagnostic Test: Multiple-Breath-WashoutPatients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics |
| Idiopathic pulmonary fibrosis | – | Diagnostic Test: Multiple-Breath-Washoutidiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines |
| Chronic obstructive pulmonary disease | – | Diagnostic Test: Multiple-Breath-WashoutChronic obstructive pulmonary disease (COPD) with/without emphysema |
| Asthma bronchiale | – | Diagnostic Test: Multiple-Breath-Washout |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the study center with one of the above-mentioned diseases
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Multiple-Breath-WashoutOne additional diagnostic test is performed using the Multiple-Breath-Washout technology | Diagnostic test | Asthma bronchiale, Cardiopulmonary healthy, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis |
Primary outcome
Lung Clearance Index
Time frame: immediately ofter the procedure
comparison of the lung clearance index of the different patient 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 7 May 2024.
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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.
Lars Hagmeyer, PD Dr. principal investigator
Wissenschaftliches Institut Bethanien e.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and COPD, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
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 8 inclusion and 3 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 7 May 2024. 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 Germany. 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?
Lung Clearance Index (time frame: immediately ofter the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.