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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01224938
Acronym
BioSput-Air
Enrollment
395
Registered
2010-10-20
Start date
2010-10-31
Completion date
2013-09-30
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Patients, Healthy Subjects

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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
sputum cytokine mRNAone year

Secondary

MeasureTime frame
lung function parametersone year
asthma symptom scoresone year
non-invasive measurements of airway inflammationone year

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026