Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3 (BioSput-Air)
Primary Purpose
Asthmatic Patients
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Montelukast
long acting beta2 mimetic
Sponsored by
About this trial
This is an interventional treatment trial for Asthmatic Patients
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
Sites / Locations
- University Hospital of Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Montelukast
long-acting beta2-mimetic
Arm Description
Outcomes
Primary Outcome Measures
sputum cytokine mRNA
Secondary Outcome Measures
responsiveness to the medication
Full Information
NCT ID
NCT01224964
First Posted
October 18, 2010
Last Updated
October 22, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01224964
Brief Title
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Acronym
BioSput-Air
Official Title
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
These subgroups have different responses to anti-leukotrienes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Title
long-acting beta2-mimetic
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Description
Montelukast, 10 mg
Intervention Type
Drug
Intervention Name(s)
long acting beta2 mimetic
Intervention Description
ICS+long acting beta2 agonist: twice daily
Primary Outcome Measure Information:
Title
sputum cytokine mRNA
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
responsiveness to the medication
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique MA Bullens, MD,PhD
Organizational Affiliation
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven F Seys, MSc
Organizational Affiliation
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
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