Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
- Registration Number
- NCT01224977
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
The main objectives of the study are:
1. To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency
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-microbial therapy with potential anti-inflammatory potency (macrolides).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- severe asthmatics (GINA step 4 or step 5 (without anti-IgE))
- viral/fungal/bacterial infection +fever (<1 month)
- asthma exacerbation (<3 months)
- other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description azithromycin azithromycin -
- Primary Outcome Measures
Name Time Method sputum cytokine mRNA 3 months
- Secondary Outcome Measures
Name Time Method responsiveness to the medication 3 months
Trial Locations
- Locations (1)
University Hospital of Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium