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

Asthmatic Patients Clinical Trial

— BioSput-Air  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01224964
• Other study ID #: Biomarker sputum airway study3
• Status: Terminated
• Phase: N/A
• First received: October 18, 2010
• Last updated: October 22, 2014
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthmatic Patients

Intervention

Drug:
• Montelukast
Montelukast, 10 mg
• long acting beta2 mimetic
ICS+long acting beta2 agonist: twice daily

Locations

Country	Name	City	State
Belgium	University Hospital of Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sputum cytokine mRNA		8 weeks	No
Secondary	responsiveness to the medication		8 weeks	No