Clinical Trials Directory

Trials / Terminated

TerminatedNCT01224964

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
1 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The main objectives of the study are: 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.

Conditions

Interventions

TypeNameDescription
DRUGMontelukastMontelukast, 10 mg
DRUGlong acting beta2 mimeticICS+long acting beta2 agonist: twice daily

Timeline

Start date
2011-01-01
Primary completion
2014-10-01
Completion
2014-10-01
First posted
2010-10-20
Last updated
2014-10-23

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT01224964. Inclusion in this directory is not an endorsement.