Exhaled BreathNCT02595632
Breath Analysis in Healthy Controls
An observational study of Exhaled Breath and Mass Spectrometry, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Exhaled Breath, Mass Spectrometry, Healthy Subjects
- How many people
- 183 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Aug 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects will be included according to the predefined inclusion and exclusion criteria. They will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
Who may be able to join
- Normal spirometry (forced expiratory volume in 1 second (FEV1) > 80%, forced vital capacity (FVC) > 80%, FEV1/FVC > 70%.).
- Age between 18 and 90 years at study entry.
Who cannot join
- Presence of an active malignancy.
- Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)
- Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pulmonary Division
Zurich, 8091
About this study
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls
The purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
- Conditions
- Exhaled Breath, Mass Spectrometry, Healthy Subjects
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy subjects with no apparent lung disease and normal lung function testing. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.
Measured: 1 day, single measurement, no follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exhaled BreathStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595632
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0187
- Status last verified
- Oct 2020
- First submitted
- 2 Nov 2015
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls
- ClinicalTrials.gov ID
- NCT02595632
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0187
- Conditions
- Exhaled Breath, Mass Spectrometry, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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 purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: No interventionHealthy subjects with no apparent lung disease and normal lung function testing. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects will be included according to the predefined inclusion and exclusion criteria. They will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
Key inclusion criteria (2 listed)
- Normal spirometry (forced expiratory volume in 1 second (FEV1) > 80%, forced vital capacity (FVC) > 80%, FEV1/FVC > 70%.).
- Age between 18 and 90 years at study entry.
Key exclusion criteria (5 listed)
- Presence of an active malignancy.
- Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)
- Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
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 |
|---|---|---|
| No intervention | Other | Healthy |
Primary outcome
The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.
Time frame: 1 day, single measurement, no follow up
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 5 Oct 2020.
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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?
An observational study of Exhaled Breath and Mass Spectrometry, 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 2 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 5 Oct 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?
The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects. (time frame: 1 day, single measurement, no follow up). 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 5 Oct 2020.