Breath Analysis in Chronic Obstructive Lung Disease (COPD)

Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)

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.

Study Overview

• Status: Completed
• Conditions: COPD

Detailed Description

This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
COPD-specific mass spectrometric exhaled breath pattern	baseline

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Malcolm Kohler, Prof., University Hospital Zurich, Pulmonary Division

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: exhaled breath; volatile organic compounds (VOCs); SESI-MS
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0088

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No