NCT02595632

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

4.8 years

First QC Date

November 2, 2015

Last Update Submit

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.

Other: No intervention

Interventions

Healthy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Study Sites (1)

University Hospital Zurich, Pulmonary Division

Zurich, 8091, Switzerland

Location

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

Locations