Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3 (BioSput-Air)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224964
First received: October 18, 2010
Last updated: October 3, 2011
Last verified: October 2011

October 18, 2010
October 3, 2011
January 2011
December 2013   (final data collection date for primary outcome measure)
sputum cytokine mRNA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224964 on ClinicalTrials.gov Archive Site
responsiveness to the medication [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthmatic Patients
  • Drug: Montelukast
    Montelukast, 10 mg
  • Drug: long acting beta2 mimetic
    ICS+long acting beta2 agonist: twice daily
  • Active Comparator: Montelukast
    Intervention: Drug: Montelukast
  • Active Comparator: long-acting beta2-mimetic
    Intervention: Drug: long acting beta2 mimetic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Belgium
 
NCT01224964
Biomarker sputum airway study3
Yes
Dominque Bullens, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
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
Universitaire Ziekenhuizen Leuven
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP