Breath Analysis in Asthma

Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Mass Spectrometry; Exhaled Breath
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich, Pulmonary Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. 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.
2. Age between 18 and 80 years at study entry.
3. Healthy controls: never-smokers, normal spirometry (baseline FEV1 > 85% predicted and FEV1/FVC greater than 0.7).

Exclusion Criteria:

1. 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)
2. Any lung disease other than asthma.
3. Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
4. Regular intake of oral steroids.
5. Active smoking habits / positive history of smoking.
6. Acute or chronic hepatic disease.
7. Renal failure or renal replacement therapy.
8. Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma; 20 patients with asthma	Other: no intervention
Controls; 20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.	Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss Federal Institute of Technology

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: KEK-ZH-Nr. 2015-0148