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NCT02595632 Clinical Trial

Breath Analysis in Healthy Controls

Healthy Subjects Clinical Trial

Official title:
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02595632
Other study ID # KEK-ZH-Nr. 2015-0187
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2015
Est. completion date August 2020

Study information
Verified date October 2020
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 183
Est. completion date August 2020
Est. primary completion date August 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

1. Normal spirometry (forced expiratory volume in 1 second (FEV1) > 80%, forced vital capacity (FVC) > 80%, FEV1/FVC > 70%.).

2. Age between 18 and 90 years at study entry.

Exclusion Criteria:

1. Presence of an active malignancy.

2. Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis)

3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.

4. Acute or chronic hepatic disease.

5. Renal failure or renal replacement therapy.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention

Locations
Country Name City State
Switzerland University Hospital Zurich, Pulmonary Division Zurich

Sponsors (2)
Lead Sponsor Collaborator
University of Zurich Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects. 1 day, single measurement, no follow up
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