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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01224951
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
90
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel 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 2
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Feb 1, 2015
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Qvar 100

Patients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening. Daily dose (400 microgram).

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.
Other Names:
  • Qvar 100

    		•
    No Intervention: Control

    Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar.

    Outcome Measures

    Primary Outcome Measures

    1. sputum cytokine mRNA levels [6 and 10 weeks]

    Secondary Outcome Measures

    1. steroid-responsiveness [6 and 10 weeks]

      We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • steroid naive asthmatics
    Exclusion Criteria:

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

    • asthma exacerbation (<3months)

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Leuven Leuven Vlaams-Brabant Belgium 3000

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01224951
    Other Study ID Numbers:
    • Biomarker sputum airway study2
    First Posted:
    Oct 20, 2010
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Asthma
    Beclomethasone

    Study Results

    No Results Posted as of Feb 6, 2018