Breath Analysis in Chronic Obstructive Lung Disease (COPD)

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186639
• Other study ID #: KEK-ZH-Nr. 2014-0088
• Status: Completed
• First received: July 2, 2014
• Last updated: March 27, 2018
• Start date: June 2014
• Est. completion date: November 2017

Study information

• Verified date: March 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD-specific mass spectrometric exhaled breath pattern		baseline