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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 has been terminated.
(A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.)
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven Identifier:
First received: October 18, 2010
Last updated: October 22, 2014
Last verified: October 2014

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:

Further study details as provided by Dominque Bullens, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • responsiveness to the medication [ Time Frame: 8 weeks ]

Enrollment: 1
Study Start Date: January 2011
Study Completion Date: October 2014
Primary Completion Date: October 2014 (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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01224964

University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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

Responsible Party: Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven Identifier: NCT01224964     History of Changes
Other Study ID Numbers: Biomarker sputum airway study3
Study First Received: October 18, 2010
Last Updated: October 22, 2014

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017