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

Healthy Subjects Clinical Trial

— BioSput-Air  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224938
• Other study ID #: Biomarker sputum airway study1
• Status: Completed
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: July 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: September 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Asthma Patients
• Healthy Subjects

Locations

Country	Name	City	State
Belgium	University Hospital of Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View 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;7:135. — View 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. Review. — View 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. 201 — View 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. Epub 2006 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sputum cytokine mRNA		one year
Secondary	lung function parameters		one year
Secondary	asthma symptom scores		one year
Secondary	non-invasive measurements of airway inflammation		one year