- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05458934
Analysis of Exhaled Breath From Patients With Lung-/Airway Diseases (BigExBrESs) (BigExBrESs)
May 28, 2026 updated by: University of Zurich
Ananlyis of exhaled breath of patients with lung-/airway diseases to identify and distinguish respiratory diseases, and improve the disease manangament.
Study Overview
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 Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Malcolm Kohler, MD
- Phone Number: +41442551111
- Email: malcolm.kohler@usz.ch
Study Contact Backup
- Name: Noriane Sievi, MSc
- Phone Number: +41442559815
- Email: noriane.sievi@usz.ch
Study Locations
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8091
- Recruiting
- University Hospital Zurich
-
Contact:
- Malcolm Kohler, MD
- Phone Number: +41442551111
- Email: malcolm.kohler@usz.ch
-
Contact:
- Noriane Sievi, MSc
- Phone Number: +41442559815
- Email: noriane.sievi@usz.ch
-
-
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
Yes
Sampling Method
Probability Sample
Study Population
General population
Description
Inclusion Criteria:
- Signed informed consent
- Age ≥ 18 years at study entry
Exclusion Criteria:
- Physical or intellectual impairment precluding informed consent or protocol adherence
- Known 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: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lung-/Airway diseases
Patients with lung-/airway diseases
|
no intervention
|
|
Controls
Participants without lung-/airway disease
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Molecular breath pattern
Time Frame: at baseline
|
Comparison of molecular weights of breath features from patients with different respiratory diseases
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in molecular breath pattern
Time Frame: over one year
|
Change in the molecular breath pattern during the course of the disease (untargeted approach)
|
over one year
|
|
Symptoms
Time Frame: at baseline
|
Correlation/Association of molecular weights of specific breath features with symptoms (e.g.
dyspnea)
|
at baseline
|
|
Inflammatory markers
Time Frame: at baseline
|
Correlation/Association of molecular weights of specific breath features with inflammatory markers (e.g.
eosinophils)
|
at baseline
|
|
Controls
Time Frame: at baseline
|
Differentiation of molecular breath pattern (m/z ratios of molecules in exhaled breath) between diseased patients and participants without respiratory disease (untargeted approach)
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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)
May 11, 2021
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
July 13, 2022
First Posted (Actual)
July 14, 2022
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2021-00539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
if requested
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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