Clinical trial NCT01224938: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
Official title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Patients
Healthy Subjects
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 395
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: sputum cytokine mRNA
timeFrame: one year
Secondary outcomes:
measure: lung function parameters
timeFrame: one year
measure: asthma symptom scores
timeFrame: one year
measure: non-invasive measurements of airway inflammation
timeFrame: one year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Dominique MA Bullens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Sven F Seys, MSc
role: STUDY_DIRECTOR
References:
citation: Bullens DM, Decraene A, Dilissen E, Meyts I, De Boeck K, Dupont LJ, Ceuppens JL. Type III IFN-lambda mRNA expression in sputum of adult and school-aged asthmatics. Clin Exp Allergy. 2008 Sep;38(9):1459-67. doi: 10.1111/j.1365-2222.2008.03045.x. Epub 2008 Jun 28.
citation: Bullens DM. Measuring T cell cytokines in allergic upper and lower airway inflammation: can we move to the clinic? Inflamm Allergy Drug Targets. 2007 Jun;6(2):81-90. doi: 10.2174/187152807780832210.
citation: Bullens DM, Truyen E, Coteur L, Dilissen E, Hellings PW, Dupont LJ, Ceuppens JL. IL-17 mRNA in sputum of asthmatic patients: linking T cell driven inflammation and granulocytic influx? Respir Res. 2006 Nov 3;7(1):135. doi: 10.1186/1465-9921-7-135.
citation: Truyen E, Coteur L, Dilissen E, Overbergh L, Dupont LJ, Ceuppens JL, Bullens DM. Evaluation of airway inflammation by quantitative Th1/Th2 cytokine mRNA measurement in sputum of asthma patients. Thorax. 2006 Mar;61(3):202-8. doi: 10.1136/thx.2005.052399. Epub 2006 Jan 31.
citation: Seys SF, Scheers H, Van den Brande P, Marijsse G, Dilissen E, Van Den Bergh A, Goeminne PC, Hellings PW, Ceuppens JL, Dupont LJ, Bullens DM. Cluster analysis of sputum cytokine-high profiles reveals diversity in T(h)2-high asthma patients. Respir Res. 2017 Feb 23;18(1):39. doi: 10.1186/s12931-017-0524-y.