Breath Analysis in Healthy Controls

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02595632
• Collaborator: Swiss Federal Institute of Technology (Other)
• Enrollment: 183
• Location: 1
• Actual Duration (Months): 57
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exhaled Breath; Mass Spectrometry; Healthy Subjects	Other: No intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 183 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects. [1 day, single measurement, no follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Pulmonary Division	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich
• Swiss Federal Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02595632
• Other Study ID Numbers: KEK-ZH-Nr. 2015-0187
• First Posted: Nov 3, 2015
• Last Update Posted: Oct 5, 2020
• Last Verified: Oct 1, 2020

Study Results

No Results Posted as of Oct 5, 2020