Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
NCT ID: NCT01224964
Last Updated: 2014-10-23
Study Results
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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TERMINATED
NA
1 participants
INTERVENTIONAL
2011-01-31
2014-10-31
Brief Summary
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1\. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists)
The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:
1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
3. These subgroups have different responses to anti-leukotrienes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Montelukast
Montelukast
Montelukast, 10 mg
long-acting beta2-mimetic
long acting beta2 mimetic
ICS+long acting beta2 agonist: twice daily
Interventions
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Montelukast
Montelukast, 10 mg
long acting beta2 mimetic
ICS+long acting beta2 agonist: twice daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* asthma exacerbation (\<3 months)
* other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
* cardiac patients using beta-blockers
18 Years
65 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Dominque Bullens
prof. dr.
Principal Investigators
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Dominique MA Bullens, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Sven F Seys, MSc
Role: STUDY_DIRECTOR
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Locations
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University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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Biomarker sputum airway study3
Identifier Type: -
Identifier Source: org_study_id
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