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Breath Analysis in Asthma

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ClinicalTrials.gov Identifier: NCT02450461
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
University of Zurich

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
Asthma Exhaled Breath Mass Spectrometry Other: no intervention

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 : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



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) [ Time Frame: 1 day, single measurement, no follow up ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450461


Locations
Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss Federal Institute of Technology

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02450461     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2015-0148
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases