NCT02186639

Brief Summary

To answer the question whether a disease specific profile of breath in patients with COPD can be detected 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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration 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

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

July 2, 2014

Last Update Submit

March 27, 2018

Conditions

COPD

Keywords

exhaled breathvolatile organic compounds (VOCs)SESI-MS

Outcome Measures

Primary Outcomes (1)

  • COPD-specific mass spectrometric exhaled breath pattern

    baseline

Study Arms (2)

COPD

40 COPD patients (20 non-frequent and 20 frequent-exacerbators). No intervention.

Controls

Subjects with no apparent lung disease and normal lung function testing. Matched for age, gender and smoking history (pack years). No intervention.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited in primary, secondary and tertiary care clinics. Healthy controls will be recruited from a community sample.

You may qualify if:

  • confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC \< 0.7) performed within the last 6 months
  • age between 18 and 80 years at study entry
  • healthy controls: normal spirometry

You may not qualify if:

  • COPD exacerbation within the last 6 weeks
  • any lung disease other than COPD
  • 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

Related Publications (1)

  • Gaugg MT, Nussbaumer-Ochsner Y, Bregy L, Engler A, Stebler N, Gaisl T, Bruderer T, Nowak N, Sinues P, Zenobi R, Kohler M. Real-Time Breath Analysis Reveals Specific Metabolic Signatures of COPD Exacerbations. Chest. 2019 Aug;156(2):269-276. doi: 10.1016/j.chest.2018.12.023. Epub 2019 Jan 24.

    PMID: 30685334DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Malcolm Kohler, Prof.

    University Hospital Zurich, Pulmonary Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

November 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CH(1)