AsthmaBioSput-AirNCT01224951
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2
A study testing Beclomethasone in people with Asthma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The main objectives of the study are: -to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids) The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Beclomethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Jul 2018
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- steroid naive asthmatics
Who cannot join
- viral/bacterial/fungal infection +fever(<1month)
- asthma exacerbation (<3months)
- other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
Trial locations and contacts
1 site in 1 country.
About this study
The main objectives of the study are:
-to unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)
Read more
The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:
- different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
- Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.
- these subgroups have different responses to anti-inflammatory treatment.
- Conditions
- Asthma
- Being tested
- Beclomethasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
Also called Qvar 100
400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.
| Study group | Role | What they receive |
|---|---|---|
| Qvar 100 | Active comparator | Patients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening.
Daily dose (400 microgram). Receives: Drug: Beclomethasone |
| Control | No intervention | Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum cytokine mRNA levels
Measured: 6 and 10 weeks
Secondary outcomes (1)
steroid-responsiveness
We will evaluate steroid-responsiveness both by objective measurements (lung function parameters) and asthma scores
Measured: 6 and 10 weeks
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 startJan 2011
- Primary completionFeb 2015
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT01224951
- Sponsor's protocol ID
- Biomarker sputum airway study2
- Acronym
- BioSput-Air
- Status last verified
- Feb 2018
- First submitted
- 18 Oct 2010
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 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 2
- ClinicalTrials.gov ID
- NCT01224951
- Acronym / sponsor ID
- BioSput-Air / Biomarker sputum airway study2
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2018 (estimated)
- 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 unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (inhaled corticosteroids)
The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:
- different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
- Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist. The investigators hypothesize that the epithelial cell cytokine, TSLP, can be increased as an early marker of airway inflammation in this latter group.
- these subgroups have different responses to anti-inflammatory treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qvar 100 | Active comparator | Drug: BeclomethasonePatients will be randomized to receive either the active arm (3/4) or a SABA as rescue medication (1/4). The patient will be asked to take Qvar 100 (2puffs) in the morning and in the evening. Daily dose (400 microgram). |
| Control | No intervention | –Patients are allowed to use their SABA as rescue medication only. During the last 4 weeks, the patients will receive 400 microgram of Qvar. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- steroid naive asthmatics
Key exclusion criteria (3 listed)
- viral/bacterial/fungal infection +fever(<1month)
- asthma exacerbation (<3months)
- other airway diseases (CF, ciliary dyskinesia, bronchiectasis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeclomethasoneAlso: Qvar 100400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar. | Drug | Qvar 100 |
Primary outcome
sputum cytokine mRNA levels
Time frame: 6 and 10 weeks
1 secondary outcome
steroid-responsiveness
Time frame: 6 and 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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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?
A study testing Beclomethasone in people with Asthma, 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: status not confirmed, as of the sponsor's last update on 6 Feb 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?
Results are not available in the source record.
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 levels (time frame: 6 and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2018.