Breath Analysis in Healthy Controls
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls
1 other identifier
observational
183
1 country
1
Brief Summary
The purpose of this study is to detect a specific profile of breath in healthy subjects 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 P50-P75 for all trials
Started Nov 2015
Longer than P75 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
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 5, 2020
October 1, 2020
4.8 years
November 2, 2015
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.
1 day, single measurement, no follow up
Study Arms (1)
Healthy
Healthy subjects with no apparent lung disease and normal lung function testing.
Interventions
Eligibility Criteria
Healthy subjects will be included according to the predefined inclusion and exclusion criteria. They will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
You may qualify if:
- Normal spirometry (forced expiratory volume in 1 second (FEV1) \> 80%, forced vital capacity (FVC) \> 80%, FEV1/FVC \> 70%.).
- Age between 18 and 90 years at study entry.
You may not qualify if:
- Presence of an active malignancy.
- Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)
- 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
Study Sites (1)
University Hospital Zurich, Pulmonary Division
Zurich, 8091, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 3, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
October 5, 2020
Record last verified: 2020-10