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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Asthmatic Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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azithromycin

Group Type OTHER

azithromycin

Intervention Type DRUG

azithromycin 500 mg 3/week for 3 months

Interventions

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azithromycin

azithromycin 500 mg 3/week for 3 months

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No