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

U

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

Asthma Patients
Healthy Subjects

Study type

Observational

Funder types

Other

Identifiers

NCT01224938
Biomarker sputum airway study1

Details and patient eligibility

About

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.

Enrollment

395 patients

Sex

All

Ages

6 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

395 participants in 2 patient groups

Asthma patients
Description:
Asthmatics of all classes of severity will be included.
Healthy control population
Description:
A healthy control population will be included to compare with the asthmatics.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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