Breath Analysis in Lung Fibrosis

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: Idiopathic Pulmonary Fibrosis; Idiopathic Lung Fibrosis
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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)	1 day

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation; Swiss Federal Institute of Technology

Publications and helpful links

General Publications

• Gaugg MT, Engler A, Bregy L, Nussbaumer-Ochsner Y, Eiffert L, Bruderer T, Zenobi R, Sinues P, Kohler M. Molecular breath analysis supports altered amino acid metabolism in idiopathic pulmonary fibrosis. Respirology. 2019 May;24(5):437-444. doi: 10.1111/resp.13465. Epub 2019 Jan 25.

Study record dates

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: Mass spectrometry; Exhaled breath analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0573