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OpenTrials
Completed

NCT Number: NCT01224938

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

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.

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Key information

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. sputum cytokine mRNA

    Time frame: one year

Secondary outcomes

  1. lung function parameters

    Time frame: one year

  2. asthma symptom scores

    Time frame: one year

  3. non-invasive measurements of airway inflammation

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: BioSput-Air

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 20, 2010
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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