Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2 (BioSput-Air)
This study is currently recruiting participants.
Verified October 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224951
First received: October 18, 2010
Last updated: October 3, 2011
Last verified: October 2011
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Purpose
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 | Intervention |
|---|---|
|
Asthma |
Drug: Beclomethasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2 |
Resource links provided by NLM:
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- sputum cytokine mRNA levels [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- steroid-responsiveness [ Time Frame: 6 and 10 weeks ] [ Designated as safety issue: No ]We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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). |
Drug: Beclomethasone
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- steroid naive asthmatics
Exclusion Criteria:
- viral/bacterial/fungal infection +fever(<1month)
- asthma exacerbation (<3months)
- other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224951
Contacts
| Contact: Sven F Seys, MSc | +32 16 346165 | sven.seys@med.kuleuven.be |
| Contact: Dominique MA Bullens, MD, PhD | +32 16 346137 | dominique.bullens@med.kuleuven.be |
Locations
| Belgium | |
| University Hospital of Leuven | Recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01224951 History of Changes |
| Other Study ID Numbers: | Biomarker sputum airway study2 |
| Study First Received: | October 18, 2010 |
| Last Updated: | October 3, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Beclomethasone |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 17, 2013