Systemic SclerosisNCT05505617
Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Holger Dressel at 1 site in Switzerland.
Trial summary
To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy people (Radtke et al. ERJ Open Res. 2021 Sep 13;7(3)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Oct 2022to 1 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with systemic sclerosis and computed tomography proven interstitial lung disease
Who may be able to join
- Confirmed diagnosis of systemic sclerosis by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR1) criteria (≥ 9 points)
- Interstitial lung disease proven with high-resolution computed tomography (HRCT)
- Written informed consent
- Age ≥ 18 years
Who cannot join
- Unstable clinical condition affecting lung function testing (i.e., major hemoptoe/-tysis or pneumothorax within the last 3 months, acute respiratory tract infection in the past two weeks), others according to the assessment of the treating physician
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis: a Randomized Crossover Trial
To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy people (Radtke et al. ERJ Open Res. 2021 Sep 13;7(3)). The extent and magnitude of between-device differences in people with lung function impairment and ventilation inhomogeneities is unknown.
Read the detailed description
The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO) in people with systemic sclerosis and proven interstitial lung disease.
- "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
- "HypAir" ("HA", Medisoft, Dinant, Belgium).
- Conditions
- Systemic Sclerosis
- Being tested
- Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.
- Keywords
- nitric oxide, DLNO
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.Other
Device: Jaeger Masterscreen TM (PFT Pro, Vyaire, Hoechberg, Germany)
Device: HypAir Medisoft (Medisoft, Dinant, Belgium)
| Study group | Role | What they receive |
|---|---|---|
| Lung diffusing capacity measurements | Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit. Receives: Other: Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Secondary outcomes (17)
Difference in carbon monoxide lung diffusing capacity (DLCO in mL.min-1.mmHg-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in Alveolar volume (VA in L)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in the rate constant for NO removal from alveolar gas (κNO in s-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in the rate constant for CO removal from alveolar gas (κCO in s-1)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in change in fractional alveolar CO concentration (ΔFA CO in %)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in breath-hold time (BHT in s)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in inspired concentrations for nitric oxide (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in expired concentrations for nitric oxide (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in inspired concentrations for carbon monoxide (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in expired concentrations for carbon monoxide (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in inspired concentrations for oxygen (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in expired concentrations for oxygen (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in inspired concentrations for helium (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in expired concentrations for helium (%)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start17 Oct 2022
- Primary completion1 May 2025
- Study completion1 Mar 2026
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 Systemic SclerosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holger Dressel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Holger Dressel, University of Zurich
- Investigators
- Holger Dressel, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505617
- Sponsor's protocol ID
- 2022-00280
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be made available upon publication in an open-access journal.
Publications
Erratum: "Lung diffusing capacity for nitric oxide measured by two commercial devices: a randomised crossover comparison in healthy adults". Thomas Radtke, Quintin de Groot, Sarah R. Haile, Marion Maggi, Connie C.W. Hsia and Holger Dressel. ERJ Open Res 2021; 7: 00193-2021. ERJ Open Res. 2021 Sep 13;7(3):50193-2021. doi: 10.1183/23120541.50193-2021. eCollection 2021 Jul.
PubMed 34527728
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05505617
- Acronym / sponsor ID
- 2022-00280
- Conditions
- Systemic Sclerosis
- Keywords
- nitric oxide, DLNO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Holger DresselUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 Aug 2022 (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.
To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy people (Radtke et al. ERJ Open Res. 2021 Sep 13;7(3)). The extent and magnitude of between-device differences in people with lung function impairment and ventilation inhomogeneities is unknown.
Detailed description
The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO) in people with systemic sclerosis and proven interstitial lung disease.
- "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
- "HypAir" ("HA", Medisoft, Dinant, Belgium).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung diffusing capacity measurements | – | Other: Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with systemic sclerosis and computed tomography proven interstitial lung disease
Key inclusion criteria (4 listed)
- Confirmed diagnosis of systemic sclerosis by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR1) criteria (≥ 9 points)
- Interstitial lung disease proven with high-resolution computed tomography (HRCT)
- Written informed consent
- Age ≥ 18 years
Key exclusion criteria (2 listed)
- Unstable clinical condition affecting lung function testing (i.e., major hemoptoe/-tysis or pneumothorax within the last 3 months, acute respiratory tract infection in the past two weeks), others according to the assessment of the treating physician
- Pregnancy
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 |
|---|---|---|
| Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.Device: Jaeger Masterscreen TM (PFT Pro, Vyaire, Hoechberg, Germany) Device: HypAir Medisoft (Medisoft, Dinant, Belgium) | Other | Lung diffusing capacity measurements |
Primary outcome
Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1)
Time frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
17 secondary outcomes
Difference in carbon monoxide lung diffusing capacity (DLCO in mL.min-1.mmHg-1)
Time frame: 1 hour
Difference in Alveolar volume (VA in L)
Time frame: 1 hour
Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1)
Time frame: 1 hour
Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1)
Time frame: 1 hour
Difference in the rate constant for NO removal from alveolar gas (κNO in s-1)
Time frame: 1 hour
Difference in the rate constant for CO removal from alveolar gas (κCO in s-1)
Time frame: 1 hour
Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm)
Time frame: 1 hour
Difference in change in fractional alveolar CO concentration (ΔFA CO in %)
Time frame: 1 hour
Difference in breath-hold time (BHT in s)
Time frame: 1 hour
Difference in inspired concentrations for nitric oxide (%)
Time frame: 1 hour
Difference in expired concentrations for nitric oxide (%)
Time frame: 1 hour
Difference in inspired concentrations for carbon monoxide (%)
Time frame: 1 hour
Difference in expired concentrations for carbon monoxide (%)
Time frame: 1 hour
Difference in inspired concentrations for oxygen (%)
Time frame: 1 hour
Difference in expired concentrations for oxygen (%)
Time frame: 1 hour
Difference in inspired concentrations for helium (%)
Time frame: 1 hour
Difference in expired concentrations for helium (%)
Time frame: 1 hour
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 22 Apr 2026.
- Background: PubMed 34527728Erratum: "Lung diffusing capacity for nitric oxide measured by two commercial devices: a randomised crossover comparison in healthy adults". Thomas Radtke, Quintin de Groot, Sarah R. Haile, Marion Maggi, Connie C.W. Hsia and Holger Dressel. ERJ Open Res 2021; 7: 00193-2021. ERJ Open Res. 2021 Sep 13;7(3):50193-2021. doi: 10.1183/23120541.50193-2021. eCollection 2021 Jul.
- Individual participant dataSharing planned: Undecided. Individual participant data will be made available upon publication in an open-access journal.
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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.
Holger Dressel, Prof principal investigator
University of Zurich
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 Systemic Sclerosis, run by Holger Dressel 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 2 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 22 Apr 2026. 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?
Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1) (time frame: 1 hour). 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 NCT05505617, 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 22 Apr 2026.