NCT01224938

Brief Summary

The main objectives of the study are

  1. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

October 18, 2010

Last Update Submit

July 12, 2018

Conditions

Asthma PatientsHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • sputum cytokine mRNA

    one year

Secondary Outcomes (3)

  • lung function parameters

    one year

  • asthma symptom scores

    one year

  • non-invasive measurements of airway inflammation

    one year

Study Arms (2)

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 Criteria

Age6 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • asthma diagnosis

You may not qualify if:

  • viral/bacterial/fungal infection with fever (\<1 month )
  • other airway diseases (CF, ciliar dyskinesia, bronchiectasis)
  • asthma exacerbation (\<3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (6)

  • Bullens DM, Decraene A, Dilissen E, Meyts I, De Boeck K, Dupont LJ, Ceuppens JL. Type III IFN-lambda mRNA expression in sputum of adult and school-aged asthmatics. Clin Exp Allergy. 2008 Sep;38(9):1459-67. doi: 10.1111/j.1365-2222.2008.03045.x. Epub 2008 Jun 28.

    PMID: 18564328BACKGROUND

  • Bullens DM. Measuring T cell cytokines in allergic upper and lower airway inflammation: can we move to the clinic? Inflamm Allergy Drug Targets. 2007 Jun;6(2):81-90. doi: 10.2174/187152807780832210.

    PMID: 17692031BACKGROUND

  • Bullens DM, Truyen E, Coteur L, Dilissen E, Hellings PW, Dupont LJ, Ceuppens JL. IL-17 mRNA in sputum of asthmatic patients: linking T cell driven inflammation and granulocytic influx? Respir Res. 2006 Nov 3;7(1):135. doi: 10.1186/1465-9921-7-135.

    PMID: 17083726BACKGROUND

  • Truyen E, Coteur L, Dilissen E, Overbergh L, Dupont LJ, Ceuppens JL, Bullens DM. Evaluation of airway inflammation by quantitative Th1/Th2 cytokine mRNA measurement in sputum of asthma patients. Thorax. 2006 Mar;61(3):202-8. doi: 10.1136/thx.2005.052399. Epub 2006 Jan 31.

    PMID: 16449261BACKGROUND

  • Seys SF, Scheers H, Van den Brande P, Marijsse G, Dilissen E, Van Den Bergh A, Goeminne PC, Hellings PW, Ceuppens JL, Dupont LJ, Bullens DM. Cluster analysis of sputum cytokine-high profiles reveals diversity in T(h)2-high asthma patients. Respir Res. 2017 Feb 23;18(1):39. doi: 10.1186/s12931-017-0524-y.

    PMID: 28231834RESULT

  • Goossens J, Jonckheere AC, De Boodt S, Dilissen E, Marain N, Decaesteker T, Cortes A, Vanoirbeek JA, Seys SF, Dupont L, Bullens DMA. Sputum Transcriptomic Analysis and Clustering Reveals Insight Into Asthma Heterogeneity. Lung. 2025 Aug 20;203(1):89. doi: 10.1007/s00408-025-00843-1.

    PMID: 40830242DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

lysed sputum cells

Study Officials

  • Dominique MA Bullens, MD, PhD

    Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

    PRINCIPAL INVESTIGATOR

  • Sven F Seys, MSc

    Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 20, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

September 1, 2013

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

BE(1)