Breath Analysis in Asthma
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma
1 other identifier
observational
60
1 country
1
Brief Summary
The purpose of this study is to answer the question whether a disease-specific profile of breath in patients with asthma can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 11, 2017
August 1, 2017
1.2 years
April 29, 2015
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath)
1 day, single measurement, no follow up
Study Arms (2)
Asthma
20 patients with asthma
Controls
20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.
Interventions
Eligibility Criteria
Patients suffering from asthma will be included according to the predefined inclusion and exclusion criteria. Healthy controls will be recruited from the general population by printed flyers, newspaper advertisements and personal communication.
You may qualify if:
- Confirmed asthma. Diagnosis of asthma is made with episodic chest symptoms and a documented reversibility of at least 12% and/or 200 ml in FEV1 after 200 ug of inhaled salbutamol or airway hyperresponsiveness in the case of normal lung function testing (PC20 methacholine \< 4mg/ml) at the time of diagnosis.
- Age between 18 and 80 years at study entry.
- Healthy controls: never-smokers, normal spirometry (baseline FEV1 \> 85% predicted and FEV1/FVC greater than 0.7).
You may not qualify if:
- Asthma exacerbation within the last 6 weeks, defined as worsening of asthma symptoms requiring a change in therapy by a physician or a change in regular asthma therapy (including short course of oral corticosteroids)
- Any lung disease other than asthma.
- Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- Regular intake of oral steroids.
- Active smoking habits / positive history of smoking.
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Swiss Federal Institute of Technologycollaborator
Study Sites (1)
University Hospital Zurich, Pulmonary Division
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 21, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
August 1, 2017
Last Updated
August 11, 2017
Record last verified: 2017-08