Lung-/Airway DiseasesBigExBrESsNCT05458934
Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)
An observational study of Lung-/Airway Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung-/Airway Diseases
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: General population
Who may be able to join
- Signed informed consent
- Age ≥ 18 years at study entry
Who cannot join
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Known pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Malcolm Kohler, MD, +41442551111, malcolm.kohler@usz.ch
Noriane Sievi, MSc, +41442559815, noriane.sievi@usz.ch
About this study
Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.
Read the detailed description
Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) [low molecular weightcomponents:< 500 Dalton (Da)]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.
- Conditions
- Lung-/Airway Diseases
- 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
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Lung-/Airway diseases | Patients with lung-/airway diseases Receives: Other: No intervention | |
| Controls | Participants without lung-/airway disease Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular breath pattern
Comparison of molecular weights of breath features from patients with different respiratory diseases
Measured: at baseline
Secondary outcomes (4)
Change in molecular breath pattern
Change in the molecular breath pattern during the course of the disease (untargeted approach)
Measured: over one year
Symptoms
Correlation/Association of molecular weights of specific breath features with symptoms (e.g. dyspnea)
Measured: at baseline
Inflammatory markers
Correlation/Association of molecular weights of specific breath features with inflammatory markers (e.g. eosinophils)
Measured: at baseline
Controls
Differentiation of molecular breath pattern (m/z ratios of molecules in exhaled breath) between diseased patients and participants without respiratory disease (untargeted approach)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start11 May 2021
- Primary completionMay 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung-/Airway DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Deep Breath Intelligence (DBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458934
- Sponsor's protocol ID
- 2021-00539
- Acronym
- BigExBrESs
- Status last verified
- May 2026
- First submitted
- 30 Jun 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: if requested
Publications
Sievi NA, Schmidt F, Baur DM, Fricke K, Herth J, Serenyi D, Roeder M, Mosca N, Vesenbeckh S, Ulrich S, Clarenbach CF, Kohler M. Metabolic effects following initiation of single-inhaler triple therapy in COPD: a prospective observational study. Mol Med. 2026 Mar 3;32(1):51. doi: 10.1186/s10020-026-01449-w.
PubMed 41776387Basler S, Fricke K, Sievi NA, Arvaji A, Schmidt F, Herth J, Baur DM, Kohler M, Ulrich S, Lichtblau M. Exploring breath metabolomics as a non-invasive tool for detecting pulmonary vascular disease. Eur Heart J Open. 2025 May 23;5(3):oeaf060. doi: 10.1093/ehjopen/oeaf060. eCollection 2025 May.
PubMed 40474893
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs)
- ClinicalTrials.gov ID
- NCT05458934
- Acronym / sponsor ID
- BigExBrESs / 2021-00539
- Conditions
- Lung-/Airway Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Deep Breath Intelligence (DBI)
- Study start
- 11 May 2021 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Jul 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.
Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.
Detailed description
Breath analysis offers a unique opportunity to non-invasively retrieve unlimited samples of relevant information on the ongoing internal biochemical processes, as parts of the most volatile components in blood reach the gas phase and are subsequently exhaled (e.g. detection of ethanol in breath). Analysis of exhaled breath provides biochemical information about the metabolism and the pathophysiological state. Chemical analysis of exhaled breath with mass spectrometry identified numerous volatile organic compounds (VOCs) [low molecular weightcomponents:< 500 Dalton (Da)]. Using Big Data analytics, specific patterns of diverse respiratory disease (e.g. for COPD and asthma) can be identified and the different diseases can be distinguished from each other. Specific Big Data Analytics might also improve the management of disease (e.g.avoiding of exacerbations) by identifying early signs of exacerbation risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung-/Airway diseases | – | Other: No interventionPatients with lung-/airway diseases |
| Controls | – | Other: No interventionParticipants without lung-/airway disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (2 listed)
- Signed informed consent
- Age ≥ 18 years at study entry
Key exclusion criteria (2 listed)
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Known 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 |
|---|---|---|
| No interventionno intervention | Other | Controls, Lung-/Airway diseases |
Primary outcome
Molecular breath pattern
Time frame: at baseline
Comparison of molecular weights of breath features from patients with different respiratory diseases
4 secondary outcomes
Change in molecular breath pattern
Time frame: over one year
Symptoms
Time frame: at baseline
Inflammatory markers
Time frame: at baseline
Controls
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 41776387Sievi NA, Schmidt F, Baur DM, Fricke K, Herth J, Serenyi D, Roeder M, Mosca N, Vesenbeckh S, Ulrich S, Clarenbach CF, Kohler M. Metabolic effects following initiation of single-inhaler triple therapy in COPD: a prospective observational study. Mol Med. 2026 Mar 3;32(1):51. doi: 10.1186/s10020-026-01449-w.
- Derived from this study: PubMed 40474893Basler S, Fricke K, Sievi NA, Arvaji A, Schmidt F, Herth J, Baur DM, Kohler M, Ulrich S, Lichtblau M. Exploring breath metabolomics as a non-invasive tool for detecting pulmonary vascular disease. Eur Heart J Open. 2025 May 23;5(3):oeaf060. doi: 10.1093/ehjopen/oeaf060. eCollection 2025 May.
- Individual participant dataSharing planned: Undecided. if requested
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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.
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 Lung-/Airway Diseases, 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 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: looking for participants now, as of the sponsor's last update on 29 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malcolm Kohler, MD (+41442551111, malcolm.kohler@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular breath pattern (time frame: at baseline). 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 NCT05458934, which also lists 2 linked publications.
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 29 May 2026.