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

NCT01224964 | Terminated DMC

• 1 other identifier: Biomarker sputum airway study3
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 3.These subgroups have different responses to anti-leukotrienes.

Conditions

Asthmatic Patients

Outcome Measures

Primary Outcomes (1)

• sputum cytokine mRNA

  8 weeks

Secondary Outcomes (1)

• responsiveness to the medication

  8 weeks

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

Drug: Montelukast

long-acting beta2-mimetic

ACTIVE COMPARATOR

Drug: long acting beta2 mimetic

Interventions

Montelukast DRUG

Montelukast, 10 mg

Montelukast

long acting beta2 mimetic DRUG

ICS+long acting beta2 agonist: twice daily

long-acting beta2-mimetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)

You may not qualify if:

• viral/fungal/bacterial infection +fever (\<1 month)
• asthma exacerbation (\<3 months)
• other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
• cardiac patients using beta-blockers

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

montelukast

Study Officials

• Dominique MA Bullens, MD,PhD

  Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

  PRINCIPAL INVESTIGATOR

• Sven F Seys, MSc

  Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

BE (1)