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Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1. (BioSput-Air)

This study has been completed.
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven Identifier:
First received: October 18, 2010
Last updated: September 25, 2013
Last verified: September 2013

The main objectives of the study are

  1. to study the different T cell subtypes (Th1, Th2, Th17 and Treg) in the lower airways of healthy subjects and clinically different asthma patients, based on a non-invasive procedure of sputum induction. Patients will be different in function of age, in relation to the trigger (eg aspirin, without or with association with polyposis), without or with underlying atopic sensitization or different in the type of underlying inflammation (eosinophilic vs neutrophilic). This T cell pattern will become the basis of molecular phenotyping in the patients.
  2. to study the usefulness of asthma molecular phenotyping (by following the balance between the inflammatory markers on the one hand and the regulatory markers on the other hand) in asthma guidance (longitudinally).

The final goal of this project is then to develop a sputum non-invasive biomarker array that can be used to distinguish the different inflammatory asthma phenotypes and that can predict steroid resistance and/or sensitivity to other anti-inflammatory medication, using a non-invasive technique that can be used also at young age and repetitively.

Asthma Patients
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA [ Time Frame: one year ]

Secondary Outcome Measures:
  • lung function parameters [ Time Frame: one year ]
  • asthma symptom scores [ Time Frame: one year ]
  • non-invasive measurements of airway inflammation [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
lysed sputum cells

Enrollment: 395
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Asthma patients
Asthmatics of all classes of severity will be included.
Healthy control population
A healthy control population will be included to compare with the asthmatics.


Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
330 asthmatics (300 adults, 30 children) will be recruited from the outpatient clinic of the university hospital of Leuven. 115 healthy subjects (100 adults, 15 children) will be recruited among students and co-workers from the KULeuven and UZ Leuven.

Inclusion Criteria:

  • asthma diagnosis

Exclusion Criteria:

  • viral/bacterial/fungal infection with fever (<1 month )
  • other airway diseases (CF, ciliar dyskinesia, bronchiectasis)
  • asthma exacerbation (<3 months)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01224938

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