AsthmaNCT02450461
Breath Analysis in Asthma
An observational study of Asthma and Exhaled Breath, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Exhaled Breath, Mass Spectrometry
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Age between 18 and 80 years at study entry.
- Healthy controls: never-smokers, normal spirometry (baseline FEV1 > 85% predicted and FEV1/FVC greater than 0.7).
Who cannot join
- 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)
- Any lung disease other than asthma.
- Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- Regular intake of oral steroids.
- Active smoking habits / positive history of smoking.
- Acute or chronic hepatic disease.
- Renal failure or renal replacement therapy.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Pulmonary Division
Zurich, 8091
About this study
Official title: 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.
- Conditions
- Asthma, Exhaled Breath, Mass Spectrometry
- Being tested
- no intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Asthma | 20 patients with asthma Receives: Other: no intervention | |
| Controls | 20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the asthma specific mass spectrometric profile of VOCs of exhaled breath analysis (markers of asthma in exhaled breath)
Measured: 1 day, single measurement, no follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450461
- Sponsor's protocol ID
- KEK-ZH-Nr. 2015-0148
- Status last verified
- Aug 2017
- First submitted
- 29 Apr 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Patients With Asthma
- ClinicalTrials.gov ID
- NCT02450461
- Acronym / sponsor ID
- KEK-ZH-Nr. 2015-0148
- Conditions
- Asthma, Exhaled Breath, Mass Spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Other: no intervention20 patients with asthma |
| Controls | – | Other: no intervention20 control subjects with no apparent lung disease and normal lung function testing. Matched for gender, age and smoking history. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Age between 18 and 80 years at study entry.
- Healthy controls: never-smokers, normal spirometry (baseline FEV1 > 85% predicted and FEV1/FVC greater than 0.7).
Key exclusion criteria (8 listed)
- 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)
- Any lung disease other than asthma.
- Acute inflammatory disease (e.g. common cold) within the last 4 weeks.
- Regular intake of oral steroids.
- Active smoking habits / positive history of smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | Asthma, Controls |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Exhaled Breath, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.