Back to resultsBreath Analysis in in Adults With Cystic Fibrosis (CF)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Venous blood markers
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis focused on measuring Breath Tests
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Pulmonary Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cystic Fibrosis
Control
Arm Description
Breath test and venous blood markers in cystic fibrosis patients
Breath test and venous blood markers in healthy subjects
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209571
Brief Title
Breath Analysis in in Adults With Cystic Fibrosis (CF)
Official Title
Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Breath Tests
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cystic Fibrosis
Arm Type
Experimental
Arm Description
Breath test and venous blood markers in cystic fibrosis patients
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Breath test and venous blood markers in healthy subjects
Intervention Type
Other
Intervention Name(s)
Venous blood markers
Intervention Description
Routine venous blood sampling
Primary Outcome Measure Information:
Title
Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
Description
Breathprints (exhalome) molecular composition expressed in intensity patterns (so-called mass-to-charge or m/z pairs)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Composite of clinical records
Description
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)
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Kohler, MD, Prof
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Pulmonary Division
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Breath Analysis in in Adults With Cystic Fibrosis (CF)
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