Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Study Overview
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Brief Summary
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The main objectives of the study are: -to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids) 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: 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. 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. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group. these subgroups have different responses to anti-inflammatory treatment.

Official Title
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Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Conditions
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Asthma

Intervention / Treatment
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* Drug: Beclomethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: steroid naive asthmatics Exclusion Criteria: viral/bacterial/fungal infection +fever(<1month) asthma exacerbation (<3months) other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Qvar 100<br>Patients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening. Daily dose (400 microgram). | Drug: Beclomethasone<br>* 400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.<br>* Other names: Qvar 100;|
| No Intervention: Control<br>Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum cytokine mRNA levels |  | 6 and 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| steroid-responsiveness | We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores | 6 and 10 weeks |