Breath Analysis in in Adults With Cystic Fibrosis (CF)

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209571
• Other study ID #: KEK-ZH-Nr. 2014-0076
• Status: Completed
• Phase: N/A
• First received: July 18, 2014
• Last updated: December 10, 2015
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Venous blood markers
Routine venous blood sampling

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)	Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)	up to 2 years	No
Secondary	Composite of clinical records	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	No