Breath Analysis in Lung Fibrosis

October 1, 2020 updated by: Malcolm Kohler, University of Zurich

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

The aim of the study is to answer the question whether a disease specific profile of breath in patients with idiopathic lung fibrosis can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Confirmed diagnosis of idiopathic pulmonary fibrosis based on clinical, radiologic and/or pathologic data without evidence or suspicion of an alternative diagnosis that may contribute to their interstitial lung disease. Patients must fulfill all of the following criteria:

Description

Inclusion Criteria:

  1. Clinical symptoms consistent with IPF
  2. Age 40 through 80 years
  3. Diagnosis of UIP or IPF by HRCT and surgical lung biopsy as outlined in table 1. Only patients fulfilling the category "YES" will be included in the study.
  4. Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
  5. No features supporting an alternative diagnosis

Exclusion Criteria:

  1. Acute exacerbation within the last 6 weeks.
  2. Any relevant lung disease other than pulmonary fibrosis.
  3. Acute inflammatory disease (e.g. common cold) within the last 6 weeks.
  4. Acute or chronic hepatic disease.
  5. Renal failure or renal replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idiopathic lung fibrosis
20 IPF patients
Other: No intervention
Controls
20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Swiss National Science Foundation
Swiss Federal Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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