Breath Analysis in in Adults With Cystic Fibrosis (CF)

December 10, 2015 updated by: University of Zurich

Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study

Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients with age and gender-matched healthy adults in order to identify a disease-specific exhaled breath pattern as well as to gain insight into pathophysiological and microbial contributions to exhaled breath composition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although there is some evidence that breath composition reflects aspects of CF pathology, so far a disease-specific molecular breath profile has not been identified. Real-time, whole breath analysis incorporating all of the thousands of potentially relevant volatile compounds is needed in order to identify reliable CF-specific breath patterns. These may be used in future clinical applications to greatly enhance cost-effectiveness and simplicity of diagnostic testing for CF.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of cystic fibrosis (for CF-patients)
  • Age ≥ 18 years

Exclusion Criteria:

  • Previous lung transplantation (for CF-patients)
  • Pulmonary exacerbation within the preceding 6 weeks (for CF-patients)
  • Moribund or severe disease prohibiting protocol adherence (for CF-patients)
  • Respiratory illness requiring physician consultation within the preceding 6 weeks (for controls)
  • Chronic respiratory illness (for controls)
  • Physical or intellectual impairment precluding informed consent or protocol adherence
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cystic Fibrosis
Breath test and venous blood markers in cystic fibrosis patients
Other: Venous blood markers
Routine venous blood sampling
Active Comparator: Control
Breath test and venous blood markers in healthy subjects
Other: Venous blood markers
Routine venous blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
Time Frame: up to 2 years
Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of clinical records
Time Frame: up to 2 years
Clinical data assessed via questionaire, venous blood markers (clinical routine markers), sputum culture results (clinical routine bacteriology) (results to be reported as a single value for each Arm/Group)
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Malcolm Kohler, MD, Prof, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0076

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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