Breath Analysis in Chronic Obstructive Lung Disease (COPD)

NCT ID: NCT02186639

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD

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

No interventions assigned to this group

Controls

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

No intervention.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malcolm Kohler, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Pulmonary Division

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30685334 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK-ZH-Nr. 2014-0088

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COPD Breathing Record Study 2
NCT03615365 COMPLETED