Back to resultsDevelopment and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2 (BioSput-Air)
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Beclomethasone
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- steroid naive asthmatics
Exclusion Criteria:
- viral/bacterial/fungal infection +fever(<1month)
- asthma exacerbation (<3months)
- other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
Sites / Locations
- University Hospital of Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Qvar 100
Control
Arm Description
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).
Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.
Outcomes
Primary Outcome Measures
sputum cytokine mRNA levels
Secondary Outcome Measures
steroid-responsiveness
We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores
Full Information
NCT ID
NCT01224951
First Posted
October 18, 2010
Last Updated
February 5, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01224951
Brief Title
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Acronym
BioSput-Air
Official Title
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
July 2018 (Anticipated)
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:
-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Qvar 100
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.
Intervention Type
Drug
Intervention Name(s)
Beclomethasone
Other Intervention Name(s)
Qvar 100
Intervention Description
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.
Primary Outcome Measure Information:
Title
sputum cytokine mRNA levels
Time Frame
6 and 10 weeks
Secondary Outcome Measure Information:
Title
steroid-responsiveness
Description
We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores
Time Frame
6 and 10 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:
steroid naive asthmatics
Exclusion Criteria:
viral/bacterial/fungal infection +fever(<1month)
asthma exacerbation (<3months)
other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
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 2
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