Asthma PatientsBioSput-AirNCT01224938
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
An observational study of Asthma Patients and Healthy Subjects, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Patients, Healthy Subjects
- How many people
- 395 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- asthma diagnosis
Who cannot join
- viral/bacterial/fungal infection with fever (<1 month )
- other airway diseases (CF, ciliar dyskinesia, bronchiectasis)
- asthma exacerbation (<3 months)
Trial locations and contacts
1 site in 1 country.
About this study
The main objectives of the study are
- 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.
- 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.
- Conditions
- Asthma Patients, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum cytokine mRNA
Measured: one year
Secondary outcomes (3)
lung function parameters
Measured: one year
asthma symptom scores
Measured: one year
non-invasive measurements of airway inflammation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asthma PatientsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominque Bullens, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Dominique MA Bullens, MD, PhD, Principal investigator, Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, BelgiëSven F Seys, MSc, Study director, Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224938
- Sponsor's protocol ID
- Biomarker sputum airway study1
- Acronym
- BioSput-Air
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2010
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18564328Bullens 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.
PubMed 17692031Bullens 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.
PubMed 17083726Truyen 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.
PubMed 16449261Seys 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.
PubMed 28231834Goossens 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.
PubMed 40830242
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 1.
- ClinicalTrials.gov ID
- NCT01224938
- Acronym / sponsor ID
- BioSput-Air / Biomarker sputum airway study1
- Conditions
- Asthma Patients, Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of the study are
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- asthma diagnosis
Key exclusion criteria (3 listed)
- viral/bacterial/fungal infection with fever (<1 month )
- other airway diseases (CF, ciliar dyskinesia, bronchiectasis)
- asthma exacerbation (<3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sputum cytokine mRNA
Time frame: one year
3 secondary outcomes
lung function parameters
Time frame: one year
asthma symptom scores
Time frame: one year
non-invasive measurements of airway inflammation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Background: PubMed 18564328Bullens 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.
- Background: PubMed 17692031Bullens 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.
- Background: PubMed 17083726Bullens 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.
- Background: PubMed 16449261Truyen 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.
- Results publication: PubMed 28231834Seys 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.
- Derived from this study: PubMed 40830242Goossens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique MA Bullens, MD, PhD principal investigator
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
Sven F Seys, MSc study director
Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Patients and Healthy Subjects, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sputum cytokine mRNA (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224938, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.