Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Overview
- Phase
- Not Applicable
- Intervention
- Beclomethasone
- Conditions
- Asthma
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- sputum cytokine mRNA levels
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Dominque Bullens
prof. dr.
Universitaire Ziekenhuizen KU Leuven
Eligibility Criteria
Inclusion Criteria
- •steroid naive asthmatics
Exclusion Criteria
- •viral/bacterial/fungal infection +fever(\<1month)
- •asthma exacerbation (\<3months)
- •other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
Arms & Interventions
Qvar 100
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).
Intervention: Beclomethasone
Outcomes
Primary Outcomes
sputum cytokine mRNA levels
Time Frame: 6 and 10 weeks
Secondary Outcomes
- steroid-responsiveness(6 and 10 weeks)