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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224938
First received: October 18, 2010
Last updated: September 25, 2013
Last verified: September 2013

October 18, 2010
September 25, 2013
October 2010
March 2012   (final data collection date for primary outcome measure)
sputum cytokine mRNA [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224938 on ClinicalTrials.gov Archive Site
  • lung function parameters [ Time Frame: one year ] [ Designated as safety issue: No ]
  • asthma symptom scores [ Time Frame: one year ] [ Designated as safety issue: No ]
  • non-invasive measurements of airway inflammation [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

lysed sputum cells

Probability Sample

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.

  • Asthma Patients
  • Healthy Subjects
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
September 2013
March 2012   (final data collection date for primary outcome measure)

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)
Both
6 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01224938
Biomarker sputum airway study1
Yes
Dominque Bullens, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
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
Universitaire Ziekenhuizen Leuven
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP