Breath Analysis in Lung Fibrosis
Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis
1 other identifier
observational
31
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 7, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 5, 2020
October 1, 2020
3.5 years
April 28, 2015
October 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)
1 day
Study Arms (2)
Idiopathic lung fibrosis
20 IPF patients
Controls
20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.
Interventions
Eligibility Criteria
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:
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Swiss Federal Institute of Technologycollaborator
- Swiss National Science Foundationcollaborator
Study Sites (1)
Pulmonary Division, University Hospital of Zurich
Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 30681243DERIVED
Biospecimen
Exhaled breath
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 7, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
October 5, 2020
Record last verified: 2020-10