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Breath Analysis in Lung Fibrosis

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ClinicalTrials.gov Identifier: NCT02437448
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : October 25, 2016
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
Swiss National Science Foundation
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Brief 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.

Condition or disease Intervention/treatment
Idiopathic Lung Fibrosis Idiopathic Pulmonary Fibrosis Other: No intervention

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Patients With Pulmonary Fibrosis
Study Start Date : June 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018


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



Primary Outcome Measures :
  1. IPF-specific mass spectrometric profile of volatile organic compounds of exhaled breath analysis (markers of IPF in exhaled breath) [ Time Frame: 1 day ]

Biospecimen Retention:   None Retained
Exhaled breath


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437448


Contacts
Contact: Malcolm Kohler +41 255 38 28 malcolm.kohler@usz.ch

Locations
Switzerland
Pulmonary Division, University Hospital of Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Malcolm Kohler, MD    0041 44 255 97 51    Malcolm.Kohler@usz.ch   
Contact: Yvonne Nussbaumer, MD    0041 44 255 38 28    yvonne.nussbaumer@usz.ch   
Principal Investigator: Malcolm Kohler, MD         
Sub-Investigator: Renato Zenobi         
Sponsors and Collaborators
University of Zurich
Swiss Federal Institute of Technology
Swiss National Science Foundation

Responsible Party: Malcolm Kohler, Prof, University of Zurich
ClinicalTrials.gov Identifier: NCT02437448     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2014-0573
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Malcolm Kohler, University of Zurich:
Mass spectrometry
Exhaled breath analysis

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial