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

This study is currently recruiting participants.
Verified October 2011 by Universitaire Ziekenhuizen Leuven
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
History of Changes
  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 Intervention
Asthmatic Patients
 Drug: Montelukast
Drug: long acting beta2 mimetic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • responsiveness to the medication [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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: Montelukast Drug: Montelukast
Montelukast, 10 mg
Active Comparator: long-acting beta2-mimetic Drug: long acting beta2 mimetic
ICS+long acting beta2 agonist: twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224964

Locations
Belgium
University Hospital of Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
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    
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: NCT01224964     History of Changes
Other Study ID Numbers: Biomarker sputum airway study3
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
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013