Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4. (BioSput-Air)
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:
- 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.
- These subgroups have different responses to anti-microbial therapy with potential anti-inflammatory potency (macrolides).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.|
- sputum cytokine mRNA [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- responsiveness to the medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: azithromycin||
azithromycin 500 mg 3/week for 3 months
|University Hospital of Leuven||Recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Sven F Seys, MSc +32 16 346165 firstname.lastname@example.org|
|Contact: Dominique MA Bullens, MD, PhD +32 16 346137 Dominique.email@example.com|
|Principal Investigator:||Dominique MA Bullens, MD,PhD||Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België|
|Study Director:||Sven F Seys, MSc||Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België|