HealthyNCT04016597
Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults
An observational study of Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Jaeger Masterscreen TM and HypAir Medisoft
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2019to 31 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people
Who may be able to join
- Age 18 years and older
Who cannot join
- Previous thoracic surgery
- Smoking
- Chronic lung disease (e.g., asthma bronchiale, COPD)
- Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry [Quanjer et al. Eur Respir J 2005]
- Current respiratory infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich and University Hospital of Zurich
Zurich, 8001
About this study
Official title: Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults
The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices.
The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO).
- "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
- "HypAir" ("HA", Medisoft, Dinant, Belgium).
Read the detailed description
In a single-center, crossover study conducted at the University Hospital Zurich, Switzerland, 35 healthy, non-smoking adults (>=18 years) will be invited to perform DLNO measurements in random order using the MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium) devices during one study visit.
The order of the tests on the MasterscreenTM and HypAir devices will be randomly allocated using central randomisation.
- Conditions
- Healthy
- Being tested
- Jaeger Masterscreen TM, HypAir Medisoft
- Keywords
- diffusing capacity, reliability, healthy, adults, nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaeger Masterscreen TMDevice
Single-breath nitric oxide lung diffusing capacity
HypAir MedisoftDevice
Single-breath nitric oxide lung diffusing capacity
| Study group | Role | What they receive |
|---|---|---|
| Lung diffusing capacity measurements | Participants perform single-breath lung diffusing capacity measurements in random order during one study visit. Receives: Device: Jaeger Masterscreen TM; Device: HypAir Medisoft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Secondary outcomes (12)
Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in Alveolar volume (L)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in inspiratory volume (L)
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Measured: 1 hour
Difference in breath-hold time (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 (in %)
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 (in %)
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 (in %)
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 (in %)
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 day
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Oct 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Radtke, PhD, Principal investigator, University of Zurich, EBPI, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016597
- Sponsor's protocol ID
- 2019-00226
- Other IDs
- 2019
- Status last verified
- Feb 2020
- First submitted
- 4 Jul 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guenard H, van der Lee I, Steenbruggen I, Naeije R, Cao J, Dinh-Xuan AT. Standardisation and application of the single-breath determination of nitric oxide uptake in the lung. Eur Respir J. 2017 Feb 8;49(2):1600962. doi: 10.1183/13993003.00962-2016. Print 2017 Feb.
PubMed 28179436
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults
- ClinicalTrials.gov ID
- NCT04016597
- Acronym / sponsor ID
- 2019-00226
- Conditions
- Healthy
- Keywords
- diffusing capacity, reliability, healthy, adults, nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Jul 2019 (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.
The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices.
The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO).
- "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
- "HypAir" ("HA", Medisoft, Dinant, Belgium).
Detailed description
In a single-center, crossover study conducted at the University Hospital Zurich, Switzerland, 35 healthy, non-smoking adults (>=18 years) will be invited to perform DLNO measurements in random order using the MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium) devices during one study visit.
The order of the tests on the MasterscreenTM and HypAir devices will be randomly allocated using central randomisation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung diffusing capacity measurements | – | Device: Jaeger Masterscreen TM, Device: HypAir MedisoftParticipants perform single-breath lung diffusing capacity measurements in random order during one study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people
Key inclusion criteria (1 listed)
- Age 18 years and older
Key exclusion criteria (5 listed)
- Previous thoracic surgery
- Smoking
- Chronic lung disease (e.g., asthma bronchiale, COPD)
- Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry [Quanjer et al. Eur Respir J 2005]
- Current respiratory infection
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 |
|---|---|---|
| Jaeger Masterscreen TMSingle-breath nitric oxide lung diffusing capacity | Device | Lung diffusing capacity measurements |
| HypAir MedisoftSingle-breath nitric oxide lung diffusing capacity | Device | Lung diffusing capacity measurements |
Primary outcome
Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)
Time frame: 1 hour
Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
12 secondary outcomes
Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)
Time frame: 1 hour
Difference in Alveolar volume (L)
Time frame: 1 hour
Difference in inspiratory volume (L)
Time frame: 1 hour
Difference in breath-hold time (s)
Time frame: 1 hour
Difference in inspired concentrations for nitric oxide (in %)
Time frame: 1 hour
Difference in expired concentrations for nitric oxide (in %)
Time frame: 1 hour
Difference in inspired concentrations for carbon monoxide (in %)
Time frame: 1 hour
Difference in expired concentrations for carbon monoxide (in %)
Time frame: 1 hour
Difference in inspired concentrations for helium (%)
Time frame: 1 hour
Difference in expired concentrations for helium (%)
Time frame: 1 day
Difference in inspired concentrations for oxygen (%)
Time frame: 1 hour
Difference in expired concentrations for oxygen (%)
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 11 Feb 2020.
- Results publication: PubMed 28179436Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guenard H, van der Lee I, Steenbruggen I, Naeije R, Cao J, Dinh-Xuan AT. Standardisation and application of the single-breath determination of nitric oxide uptake in the lung. Eur Respir J. 2017 Feb 8;49(2):1600962. doi: 10.1183/13993003.00962-2016. Print 2017 Feb.
- 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.
Thomas Radtke, PhD principal investigator
University of Zurich, EBPI, Switzerland
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 Healthy, run by University of Zurich 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 1 inclusion and 5 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 11 Feb 2020. 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 (mL/min/mmHg) (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 NCT04016597, 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 11 Feb 2020.