Idiopathic Lung FibrosisNCT02437448
Breath Analysis in Lung Fibrosis
An observational study of Idiopathic Lung Fibrosis and Idiopathic Pulmonary Fibrosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis 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 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Lung Fibrosis, Idiopathic Pulmonary Fibrosis
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 2018
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Confirmed diagnosis of idiopathic pulmonary fibrosis based on clinical, radiologic and/or pathologic data without evidence or suspicion of an alternative diagnosis that may contribute to their interstitial lung disease. Patients must fulfill all of the following criteria:
Who may be able to join
- Clinical symptoms consistent with IPF
- Age 40 through 80 years
- Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category "YES" will be included in the study.
- Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
- No features supporting an alternative diagnosis
Who cannot join
- Acute exacerbation within the last 6 weeks.
- Any relevant lung disease other than pulmonary fibrosis.
- 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
Pulmonary Division, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis
The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
- Being tested
- No intervention
- Keywords
- Mass spectrometry, Exhaled breath analysis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
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 |
|---|---|---|
| Idiopathic lung fibrosis | 20 IPF patients Receives: Other: No intervention | |
| Controls | 20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
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 Idiopathic Lung FibrosisStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Swiss National Science Foundation
- Responsible party
- Principal investigator, Malcolm Kohler, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437448
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0573
- Status last verified
- Oct 2020
- First submitted
- 28 Apr 2015
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaugg MT, Engler A, Bregy L, Nussbaumer-Ochsner Y, Eiffert L, Bruderer T, Zenobi R, Sinues P, Kohler M. Molecular breath analysis supports altered amino acid metabolism in idiopathic pulmonary fibrosis. Respirology. 2019 May;24(5):437-444. doi: 10.1111/resp.13465. Epub 2019 Jan 25.
PubMed 30681243
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 - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02437448
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0573
- Keywords
- Mass spectrometry, Exhaled breath analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology, Swiss National Science Foundation
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 May 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 aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic lung fibrosis | – | Other: No intervention20 IPF patients |
| Controls | – | Other: No intervention20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed diagnosis of idiopathic pulmonary fibrosis based on clinical, radiologic and/or pathologic data without evidence or suspicion of an alternative diagnosis that may contribute to their interstitial lung disease. Patients must fulfill all of the following criteria:
Key inclusion criteria (5 listed)
- Clinical symptoms consistent with IPF
- Age 40 through 80 years
- Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category "YES" will be included in the study.
- Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
- No features supporting an alternative diagnosis
Key exclusion criteria (5 listed)
- Acute exacerbation within the last 6 weeks.
- Any relevant lung disease other than pulmonary fibrosis.
- 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 | Controls, Idiopathic lung fibrosis |
Primary outcome
IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)
Time frame: 1 day
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.
- Derived from this study: PubMed 30681243Gaugg MT, Engler A, Bregy L, Nussbaumer-Ochsner Y, Eiffert L, Bruderer T, Zenobi R, Sinues P, Kohler M. Molecular breath analysis supports altered amino acid metabolism in idiopathic pulmonary fibrosis. Respirology. 2019 May;24(5):437-444. doi: 10.1111/resp.13465. Epub 2019 Jan 25.
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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 Idiopathic Lung Fibrosis and Idiopathic Pulmonary Fibrosis, 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 5 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?
IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath) (time frame: 1 day). 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 NCT02437448, 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 5 Oct 2020.