Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Overview[ - collapse ][ - ]
| Purpose | The main objectives of the study are: 1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists) 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. 3. These subgroups have different responses to anti-leukotrienes. |
|---|---|
| Condition | Asthmatic Patients |
| Intervention | Drug: Montelukast Drug: long acting beta2 mimetic |
| Phase | N/A |
| Sponsor | Universitaire Ziekenhuizen Leuven |
| Responsible Party | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier | NCT01224964 |
| First Received | October 18, 2010 |
| Last Updated | October 3, 2011 |
| Last verified | October 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 18, 2010 |
|---|---|
| Last Updated Date | October 3, 2011 |
| Start Date | January 2011 |
| Estimated Primary Completion Date | July 2014 |
| Current Primary Outcome Measures | sputum cytokine mRNA [Time Frame: 8 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | responsiveness to the medication [Time Frame: 8 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3 |
|---|---|
| Official Title | Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3 |
| Brief Summary | The main objectives of the study are: 1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists) 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. 3. These subgroups have different responses to anti-leukotrienes. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Asthmatic Patients |
| Intervention | Drug: Montelukast Montelukast, 10 mg Drug: long acting beta2 mimetic ICS+long acting beta2 agonist: twice daily |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | July 2014 |
| Estimated Primary Completion Date | December 2013 |
| Eligibility Criteria | Inclusion Criteria: - uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA) Exclusion Criteria: - viral/fungal/bacterial infection +fever (<1 month) - asthma exacerbation (<3 months) - other respiratory disease (CF, ciliary dyskinesia,bronchiectasis) - cardiac patients using beta-blockers |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Belgium |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01224964 |
|---|---|
| Other Study ID Numbers | Biomarker sputum airway study3 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Universitaire Ziekenhuizen Leuven |
| Study Sponsor | Universitaire Ziekenhuizen Leuven |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Dominique MA Bullens, MD,PhD Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, BelgiëStudy Director: Sven F Seys, MSc Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België |
| Verification Date | October 2011 |
Locations[ + expand ][ + ]
| University Hospital of Leuven | Leuven, Vlaams-Brabant, Belgium, 3000 Contact: Sven F Seys, MSc | +32 16 346165 | sven.seys@med.kuleuven.beRecruiting |
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