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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominque Bullens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224938
First received: October 18, 2010
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition
Asthma Patients
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • sputum cytokine mRNA [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

lysed sputum cells


Enrollment: 395
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224938

Locations
Belgium
University Hospital of Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen 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
  More Information

Publications:
Responsible Party: Dominque Bullens, prof. dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01224938     History of Changes
Other Study ID Numbers: Biomarker sputum airway study1
Study First Received: October 18, 2010
Last Updated: September 25, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014