Breath Analysis in Asthma

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT02450461
• Collaborator: Swiss Federal Institute of Technology (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Exhaled Breath; Mass Spectrometry	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Pulmonary Division	Zurich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich
• Swiss Federal Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT02450461
• Other Study ID Numbers: KEK-ZH-Nr. 2015-0148
• First Posted: May 21, 2015
• Last Update Posted: Aug 11, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Aug 11, 2017