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

July 12, 2018 updated by: Dominque Bullens, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

395

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospital of Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sputum cytokine mRNA
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
lung function parameters
Time Frame: one year
one year
asthma symptom scores
Time Frame: one year
one year
non-invasive measurements of airway inflammation
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biomarker sputum airway study1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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