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

This study is currently recruiting participants.

Verified October 2011 by Universitaire Ziekenhuizen Leuven

Sponsor:

Information provided by (Responsible Party):

Dominque Bullens, Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01224938

First received: October 18, 2010

Last updated: October 3, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2010

Last Updated Date

October 3, 2011

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

sputum cytokine mRNA [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01224938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The main objectives of the study are

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.
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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

lysed sputum cells

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.

Condition ^ICMJE

Asthma Patients
Healthy Subjects

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

445

Estimated Completion Date

October 2013

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

6 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Sven F Seys, MSc	+32 16 346165	sven.seys@med.kuleuven.be
Contact: Dominique MA Bullens, MD, PhD	+32 16 346137	dominique.bullens@med.kuleuven.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01224938

Other Study ID Numbers ^ICMJE

Biomarker sputum airway study1

Has Data Monitoring Committee

Yes

Responsible Party

Dominque Bullens, Universitaire Ziekenhuizen Leuven

Study Sponsor ^ICMJE

Universitaire Ziekenhuizen Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Universitaire Ziekenhuizen Leuven

Verification Date

October 2011

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

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