Breath Analysis in in Adults With Cystic Fibrosis (CF)

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Other: Venous blood markers
    • Routine venous blood sampling

Arms, Groups and Cohorts

  • Experimental: Cystic Fibrosis
    • Breath test and venous blood markers in cystic fibrosis patients
  • Active Comparator: Control
    • Breath test and venous blood markers in healthy subjects

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Malcolm Kohler, MD, Prof, Principal Investigator, University of Zurich

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