Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1. (BioSput-Air)
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|ClinicalTrials.gov Identifier: NCT01224938|
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : September 27, 2013
The main objectives of the study are
- 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.
- 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.
|Condition or disease|
|Asthma Patients Healthy Subjects|
|Study Type :||Observational|
|Actual Enrollment :||395 participants|
|Official Title:||Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||September 2013|
Asthmatics of all classes of severity will be included.
Healthy control population
A healthy control population will be included to compare with the asthmatics.
- sputum cytokine mRNA [ Time Frame: one year ]
- lung function parameters [ Time Frame: one year ]
- asthma symptom scores [ Time Frame: one year ]
- non-invasive measurements of airway inflammation [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224938
|University Hospital of Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|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|