Breath Analysis in Healthy Controls | NCT02595632

Studies
Breath Analysis in Healthy Controls

NCT02595632

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 5, 2020Actual

Enrollment

183Actual

Phase

Not provided

Conditions

Exhaled Breath
Mass Spectrometry
Healthy Subjects

Interventions

No intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Aug 2020Actual

Completion Date

Aug 2020Actual

First Submitted Date

Nov 2, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2020

Last Update Posted Date

Oct 5, 2020Actual

Name	Class
Swiss Federal Institute of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy subjects with no apparent lung disease and normal lung function testing.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Healthy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Pulmonary Division		Zurich		8091	Switzerland