COPDNCT04531293
Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics
A study testing Respiratory Analysis System in people with COPD, run by ndd Medizintechnik AG at 1 site in Switzerland.
Trial summary
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Respiratory Analysis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Dec 2020to 11 Apr 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 3 groups
- Healthy subjects, FEV1/FEV1(pred) > 80%
- COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%
- COPD GOLD classification 3 or 4, FEV1/FEV1(pred) < 50%
Who cannot join
- Smoked during 2 hours prior to measurements
- Additional exclusion criteria for healthy subjects:
- BMI > 30
- Any relevant concomitant diseases (investigators decision)
- Any relevant concomitant medication (investigators decision)
- FEV1/FEV1(pred) <= 80%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.
Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.
- Conditions
- COPD
- Being tested
- Respiratory Analysis System
- Keywords
- COPD, DLCO, spirometry, alveolar volume, body plethysmography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Analysis SystemDevice
Also called EasyOne Pro (TM) by ndd Medizintechnik AG
Measurement of total lung capacity using total-breath method
Respiratory Analysis SystemDevice
Also called Masterscreen (TM) by Vyaire
Measurement of total lung capacity using standard method
| Study group | Role | What they receive |
|---|---|---|
| Total-breath method followed by standard method | Other | Total Lung Capacity (TLC) measurement performed on device EasyOne Pro (TM) according to total-breath method followed by TLC measurement performed on device MasterScreen (TM) according to standard method. Receives: Device: Respiratory Analysis System |
| Standard method followed by total breath method | Other | Total Lung Capacity (TLC) measurement performed on device Masterscreen (TM) according to standard method followed by TLC measurement performed on device EasyOne Pro (TM) according to total-breath method. Receives: Device: Respiratory Analysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method
Difference in Total Lung Capacity (TLC) using total-breath method (according to ATS/ERS standard 2017, EasyOne Pro) and TLC using normal dilution method (according to ATS/ERS standard 2005, EasyOne Pro) in relation to TLC using body plethysmography (Vyaire).
Measured: single measurement on day 1
Secondary outcomes (2)
Dependency between primary outcome and COPD disease severity
Correlation between ( TLC(dilution, total-breath, EasyOne Pro) - TLC(dilution, standard 2005, EasyOne Pro) ) / TLC(body, Vyaire) and FEV1(EasyOne Pro) / FEV1(predicted)
Measured: single measurement on day 1
Device comparison using the same method for both devices.
Total Lung Capacity (TLC) (dilution, standard 2005, EasyOne Pro) / TLC(dilution, standard, Vyaire). Determines accuracy and comparability of both devices in measurement of TLC.
Measured: single measurement on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start31 Dec 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- ndd Medizintechnik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531293
- Sponsor's protocol ID
- EOP17
- Status last verified
- Jun 2022
- First submitted
- 18 Aug 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jorres RA, Buess C, Piecyk A, Thompson B, Stanojevic S, Magnussen H. The total-breath method yields higher values of DLCO and TLC than the conventional method. BMC Pulm Med. 2024 Mar 13;24(1):127. doi: 10.1186/s12890-024-02932-y.
PubMed 38475751
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics
- ClinicalTrials.gov ID
- NCT04531293
- Acronym / sponsor ID
- EOP17
- Conditions
- COPD
- Keywords
- COPD, DLCO, spirometry, alveolar volume, body plethysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- ndd Medizintechnik AGIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 28 Aug 2020 (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.
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.
Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total-breath method followed by standard method | Other | Device: Respiratory Analysis SystemTotal Lung Capacity (TLC) measurement performed on device EasyOne Pro (TM) according to total-breath method followed by TLC measurement performed on device MasterScreen (TM) according to standard method. |
| Standard method followed by total breath method | Other | Device: Respiratory Analysis SystemTotal Lung Capacity (TLC) measurement performed on device Masterscreen (TM) according to standard method followed by TLC measurement performed on device EasyOne Pro (TM) according to total-breath method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 3 groups
- Healthy subjects, FEV1/FEV1(pred) > 80%
- COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%
- COPD GOLD classification 3 or 4, FEV1/FEV1(pred) < 50%
Key exclusion criteria (6 listed)
- Smoked during 2 hours prior to measurements
- BMI > 30
- Any relevant concomitant diseases (investigators decision)
- Any relevant concomitant medication (investigators decision)
- FEV1/FEV1(pred) <= 80%
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 |
|---|---|---|
| Respiratory Analysis SystemAlso: EasyOne Pro (TM) by ndd Medizintechnik AGMeasurement of total lung capacity using total-breath method | Device | Standard method followed by total breath method, Total-breath method followed by standard method |
| Respiratory Analysis SystemAlso: Masterscreen (TM) by VyaireMeasurement of total lung capacity using standard method | Device | Standard method followed by total breath method, Total-breath method followed by standard method |
Primary outcome
Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method
Time frame: single measurement on day 1
Difference in Total Lung Capacity (TLC) using total-breath method (according to ATS/ERS standard 2017, EasyOne Pro) and TLC using normal dilution method (according to ATS/ERS standard 2005, EasyOne Pro) in relation to TLC using body plethysmography (Vyaire).
2 secondary outcomes
Dependency between primary outcome and COPD disease severity
Time frame: single measurement on day 1
Device comparison using the same method for both devices.
Time frame: single measurement on day 1
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 6 Jun 2022.
- Derived from this study: PubMed 38475751Jorres RA, Buess C, Piecyk A, Thompson B, Stanojevic S, Magnussen H. The total-breath method yields higher values of DLCO and TLC than the conventional method. BMC Pulm Med. 2024 Mar 13;24(1):127. doi: 10.1186/s12890-024-02932-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Analysis System in people with COPD, run by ndd Medizintechnik AG at 1 site in Switzerland.
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 4 inclusion and 6 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 6 Jun 2022. 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 Switzerland. 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?
Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method (time frame: single measurement on day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04531293, which also lists 1 linked publication.
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 6 Jun 2022.