Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Not Applicable

• Conditions: Asthma
• Interventions: Drug: Beclomethasone

• Registration Number: NCT01224951
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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:

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. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.

3. these subgroups have different responses to anti-inflammatory treatment.

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
• Primary Completion: 2015-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• steroid naive asthmatics

Exclusion Criteria

• viral/bacterial/fungal infection +fever(<1month)
• asthma exacerbation (<3months)
• other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qvar 100	Beclomethasone	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).

Primary Outcome Measures

Name	Time	Method
sputum cytokine mRNA levels	6 and 10 weeks

Secondary Outcome Measures

Name	Time	Method
steroid-responsiveness	6 and 10 weeks	We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores

Trial Locations

Locations (1)

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