Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2 (BioSput-Air)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01224951|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2010
Last Update Posted : February 6, 2018
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:
- 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.
- 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.
- these subgroups have different responses to anti-inflammatory treatment.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Beclomethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Qvar 100
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).
400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.
Other Name: Qvar 100
No Intervention: Control
Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.
- sputum cytokine mRNA levels [ Time Frame: 6 and 10 weeks ]
- steroid-responsiveness [ Time Frame: 6 and 10 weeks ]We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores
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): NCT01224951
|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|