Breath Analysis in in Adults With Cystic Fibrosis (CF)

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Venous blood markers

• Registration Number: NCT02209571
• Lead Sponsor: University of Zurich

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Study Start: 2014-10
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis	Venous blood markers	Breath test and venous blood markers in cystic fibrosis patients
Control	Venous blood markers	Breath test and venous blood markers in healthy subjects

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Composite of clinical records	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)

Trial Locations

Locations (1)

University Hospital Zurich, Pulmonary Division; 🇨🇭 Zurich, Switzerland