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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven Identifier:
First received: October 18, 2010
Last updated: June 9, 2016
Last verified: June 2016

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 Intervention
Drug: Beclomethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA levels [ Time Frame: 6 and 10 weeks ]

Secondary Outcome Measures:
  • steroid-responsiveness [ Time Frame: 6 and 10 weeks ]
    We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: July 2018
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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)
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Please refer to this study by its identifier: NCT01224951

University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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
  More Information

Responsible Party: Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven Identifier: NCT01224951     History of Changes
Other Study ID Numbers: Biomarker sputum airway study2
Study First Received: October 18, 2010
Last Updated: June 9, 2016

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 26, 2017