Breath Analysis in Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450461
• Other study ID #: KEK-ZH-Nr. 2015-0148
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: August 9, 2017
• Start date: April 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Exhaled Breath
• Mass Spectrometry

Intervention

Other:
• no intervention

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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