Breath Analysis in Lung Fibrosis | NCT02437448

Studies
Breath Analysis in Lung Fibrosis

NCT02437448

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 5, 2020Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Idiopathic Lung Fibrosis
Idiopathic Pulmonary Fibrosis

Interventions

No intervention

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Apr 28, 2015

First Submission Date that Met QC Criteria

May 6, 2015

First Posted Date

May 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2020

Last Update Posted Date

Oct 5, 2020Actual

Name	Class
Swiss Federal Institute of Technology	OTHER
Swiss National Science Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Controls Idiopathic lung fibrosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical symptoms consistent with IPF
Age 40 through 80 years
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.
Extent of fibrotic changes (honeycombing, reticular changes) greater than extent of emphysema on HRCT scan
No features supporting an alternative diagnosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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:

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Division, University Hospital of Zurich		Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30681243	Derived	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.

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases