COPDNCT02186639
Breath Analysis in Chronic Obstructive Lung Disease (COPD)
An observational study of COPD, run by University of Zurich at 1 site in Switzerland.
Trial summary
To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2014to Nov 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited in primary, secondary and tertiary care clinics. Healthy controls will be recruited from a community sample.
Who may be able to join
- confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC < 0.7) performed within the last 6 months
- age between 18 and 80 years at study entry
- healthy controls: normal spirometry
Who cannot join
- COPD exacerbation within the last 6 weeks
- any lung disease other than COPD
- 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 in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)
To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Read the detailed description
This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.
- Conditions
- COPD
- Keywords
- exhaled breath, volatile organic compounds (VOCs), SESI-MS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | 40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention. | |
| Controls | Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years). No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD-specific mass spectrometric exhaled breath pattern
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionNov 2017
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 COPDStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, Prof., Principal investigator, University Hospital Zurich, Pulmonary Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186639
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0088
- Status last verified
- Mar 2018
- First submitted
- 2 Jul 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaugg MT, Nussbaumer-Ochsner Y, Bregy L, Engler A, Stebler N, Gaisl T, Bruderer T, Nowak N, Sinues P, Zenobi R, Kohler M. Real-Time Breath Analysis Reveals Specific Metabolic Signatures of COPD Exacerbations. Chest. 2019 Aug;156(2):269-276. doi: 10.1016/j.chest.2018.12.023. Epub 2019 Jan 24.
PubMed 30685334
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)
- ClinicalTrials.gov ID
- NCT02186639
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0088
- Conditions
- COPD
- Keywords
- exhaled breath, volatile organic compounds (VOCs), SESI-MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Jul 2014 (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.
To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Detailed description
This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention. |
| Controls | – | –Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years). No intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in primary, secondary and tertiary care clinics. Healthy controls will be recruited from a community sample.
Key inclusion criteria (3 listed)
- confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC < 0.7) performed within the last 6 months
- age between 18 and 80 years at study entry
- healthy controls: normal spirometry
Key exclusion criteria (5 listed)
- COPD exacerbation within the last 6 weeks
- any lung disease other than COPD
- 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.
Primary outcome
COPD-specific mass spectrometric exhaled breath pattern
Time frame: baseline
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 29 Mar 2018.
- Derived from this study: PubMed 30685334Gaugg MT, Nussbaumer-Ochsner Y, Bregy L, Engler A, Stebler N, Gaisl T, Bruderer T, Nowak N, Sinues P, Zenobi R, Kohler M. Real-Time Breath Analysis Reveals Specific Metabolic Signatures of COPD Exacerbations. Chest. 2019 Aug;156(2):269-276. doi: 10.1016/j.chest.2018.12.023. Epub 2019 Jan 24.
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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.
Malcolm Kohler, Prof. principal investigator
University Hospital Zurich, Pulmonary Division
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 COPD, 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 3 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 29 Mar 2018. 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?
COPD-specific mass spectrometric exhaled breath pattern (time frame: 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 NCT02186639, 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 29 Mar 2018.