Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Completed

• Conditions: Asthma Patients; Healthy Subjects

• Registration Number: NCT01224938
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The main objectives of the study are

1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of healthy subjects and clinically different asthma patients, based on a non-invasive procedure of sputum induction. Patients will be different in function of age, in relation to the trigger (eg aspirin, without or with association with polyposis), without or with underlying atopic sensitization or different in the type of underlying inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis of molecular phenotyping in the patients.

2. to study the usefulness of asthma molecular phenotyping (by following the balance between the inflammatory markers on the one hand and the regulatory markers on the other hand) in asthma guidance (longitudinally).

The final goal of this project is then to develop a sputum non-invasive biomarker array that can be used to distinguish the different inflammatory asthma phenotypes and that can predict steroid resistance and/or sensitivity to other anti-inflammatory medication, using a non-invasive technique that can be used also at young age and repetitively.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2012-03
• Study Completion: 2013-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

• asthma diagnosis

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sputum cytokine mRNA	one year

Secondary Outcome Measures

Name	Time	Method
lung function parameters	one year
asthma symptom scores	one year
non-invasive measurements of airway inflammation	one year

Trial Locations

Locations (1)

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