Breath Analysis in Asthma

NCT ID: NCT02450461

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Exhaled Breath Mass Spectrometry

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthma

20 patients with asthma

no intervention

Intervention Type OTHER

Controls

20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history.

no intervention

Intervention Type OTHER

Interventions

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no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr. 2015-0148

Identifier Type: -

Identifier Source: org_study_id

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