Breath Analysis in Lung Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437448
• Other study ID #: KEK-ZH-Nr. 2014-0573
• Status: Completed
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Lung Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• No intervention

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath)		1 day