Breath Analysis in Healthy Controls

October 1, 2020 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich, Pulmonary Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy
Healthy subjects with no apparent lung disease and normal lung function testing.
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects.
Time Frame: 1 day, single measurement, no follow up
1 day, single measurement, no follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KEK-ZH-Nr. 2015-0187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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