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

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).

Study Overview

• Status: Unknown
• Conditions: Asthmatic Patients
• Intervention / Treatment: Drug: azithromycin

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • University Hospital of Leuven
      • Contact: Sven F Seys, PhD; Phone Number: +32 16 346165; Email: sven.seys@med.kuleuven.be
      • Contact: Dominique MA Bullens, MD, PhD; Phone Number: +32 16 346137; Email: Dominique.bullens@med.kuleuven.be
      • Sub-Investigator: Tatjana Decaesteker, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: azithromycin	Drug: azithromycin; azithromycin 500 mg 3/week for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sputum cytokine mRNA	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
responsiveness to the medication	3 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Study Director: Sven F Seys, MSc, Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België; Principal Investigator: Dominique MA Bullens, MD,PhD, Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: Biomarker sputum airway study4