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

Not Applicable

Terminated

• Conditions: Asthmatic Patients
• Interventions: Drug: Montelukast; Drug: long acting beta2 mimetic

• Registration Number: NCT01224964
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Study Start: 2011-01
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)

Exclusion Criteria

• viral/fungal/bacterial infection +fever (<1 month)
• asthma exacerbation (<3 months)
• other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
• cardiac patients using beta-blockers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Montelukast	Montelukast	-
long-acting beta2-mimetic	long acting beta2 mimetic	-

Primary Outcome Measures

Name	Time	Method
sputum cytokine mRNA	8 weeks

Secondary Outcome Measures

Name	Time	Method
responsiveness to the medication	8 weeks

Trial Locations

Locations (1)

University Hospital of Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium