Breath Analysis in Lung Fibrosis

NCT ID: NCT02437448

Last Updated: 2020-10-05

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

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Lung Fibrosis Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic lung fibrosis

20 IPF patients

No intervention

Intervention Type OTHER

Controls

20 subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.

No intervention

Intervention Type OTHER

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Malcolm Kohler

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pulmonary Division, University Hospital of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 30681243 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2014-0573

Identifier Type: -

Identifier Source: org_study_id

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