Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Asthma Clinical Trial

— BioSput-Air  

Official title:

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01224951
• Other study ID #: Biomarker sputum airway study2
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2010
• Last updated: February 5, 2018
• Start date: January 2011
• Est. completion date: July 2018

Study information

• Verified date: February 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objectives of the study are:

-to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)

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. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.

3. these subgroups have different responses to anti-inflammatory treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• steroid naive asthmatics

Exclusion Criteria:

• viral/bacterial/fungal infection +fever(<1month)

• asthma exacerbation (<3months)

• other airway diseases (CF, ciliary dyskinesia, bronchiectasis)

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Beclomethasone
400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.

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 levels		6 and 10 weeks
Secondary	steroid-responsiveness	We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores	6 and 10 weeks