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

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ClinicalTrials.gov Identifier: NCT01224977
Recruitment Status : Recruiting
First Posted : October 20, 2010
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven

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).

Condition or disease Intervention/treatment Phase
Asthmatic Patients Drug: azithromycin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
Study Start Date : July 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
azithromycin Drug: azithromycin
azithromycin 500 mg 3/week for 3 months




Primary Outcome Measures :
  1. sputum cytokine mRNA [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. responsiveness to the medication [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224977


Locations
Belgium
University Hospital of Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Sven F Seys, PhD    +32 16 346165    sven.seys@med.kuleuven.be   
Contact: Dominique MA Bullens, MD, PhD    +32 16 346137    Dominique.bullens@med.kuleuven.be   
Sub-Investigator: Tatjana Decaesteker, MSc         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Dominique MA Bullens, MD,PhD Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Study Director: Sven F Seys, MSc Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

Responsible Party: Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01224977     History of Changes
Other Study ID Numbers: Biomarker sputum airway study4
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018