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Clinical Trials/NCT01224977
NCT01224977
Unknown
Not Applicable

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country20 target enrollmentJuly 2011
Interventionsazithromycin

Overview

Phase
Not Applicable
Intervention
azithromycin
Conditions
Asthmatic Patients
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
20
Locations
1
Primary Endpoint
sputum cytokine mRNA
Last Updated
7 years ago

Overview

Brief Summary

The main objectives of the study are:

  1. To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency

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-microbial therapy with potential anti-inflammatory potency (macrolides).
Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dominque Bullens

prof. dr.

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • severe asthmatics (GINA step 4 or step 5 (without anti-IgE))

Exclusion Criteria

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

Arms & Interventions

azithromycin

Intervention: azithromycin

Outcomes

Primary Outcomes

sputum cytokine mRNA

Time Frame: 3 months

Secondary Outcomes

  • responsiveness to the medication(3 months)

Study Sites (1)

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