Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

April 17, 2026 updated by: Holger Dressel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

  1. "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
  2. "HypAir" ("HA", Medisoft, Dinant, Belgium).

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8001
        • University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with systemic sclerosis and computed tomography proven interstitial lung disease

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in carbon monoxide lung diffusing capacity (DLCO 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).
1 hour
Difference in Alveolar volume (VA in L)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
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
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
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
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in the rate constant for NO removal from alveolar gas (κNO in s-1)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in the rate constant for CO removal from alveolar gas (κCO in s-1)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in change in fractional alveolar CO concentration (ΔFA CO in %)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in breath-hold time (BHT in s)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for nitric oxide (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for nitric oxide (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for carbon monoxide (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for carbon monoxide (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for oxygen (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for oxygen (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in inspired concentrations for helium (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour
Difference in expired concentrations for helium (%)
Time Frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holger Dressel

Collaborators

University of Zurich

Investigators

  • Principal Investigator: Holger Dressel, Prof, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will be made available upon publication in an open-access journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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