Asthmatic PatientsBioSput-AirNCT01224964
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 3
A study testing Montelukast and long acting beta2 mimetic in people with Asthmatic Patients, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The main objectives of the study are: 1. To unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists) 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
- Asthmatic Patients
- What is being tested?
- Montelukast and long acting beta2 mimetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Oct 2014
- 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
- uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)
Who cannot join
- viral/fungal/bacterial infection +fever (<1 month)
- asthma exacerbation (<3 months)
- other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
- cardiac patients using beta-blockers
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 (leukotriene antagonists)
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.
- These subgroups have different responses to anti-leukotrienes.
- Conditions
- Asthmatic Patients
- Being tested
- Montelukast, long acting beta2 mimetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast, 10 mg
long acting beta2 mimeticDrug
ICS+long acting beta2 agonist: twice daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | Not described Receives: Drug: Montelukast |
| long-acting beta2-mimetic | Active comparator | Not described Receives: Drug: long acting beta2 mimetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum cytokine mRNA
Measured: 8 weeks
Secondary outcomes (1)
responsiveness to the medication
Measured: 8 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 completionOct 2014
- Study completionOct 2014
Why it stopped: A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthmatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1 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
- NCT01224964
- Sponsor's protocol ID
- Biomarker sputum airway study3
- Acronym
- BioSput-Air
- Status last verified
- Oct 2014
- First submitted
- 18 Oct 2010
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. 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 3
- ClinicalTrials.gov ID
- NCT01224964
- Acronym / sponsor ID
- BioSput-Air / Biomarker sputum airway study3
- Conditions
- Asthmatic Patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (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 unravel the importance of molecular phenotyping in predicting the response to classical anti-asthma treatment (leukotriene antagonists)
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.
- These subgroups have different responses to anti-leukotrienes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: Montelukast |
| long-acting beta2-mimetic | Active comparator | Drug: long acting beta2 mimetic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- uncontrolled persistent asthmatics on daily inhaled corticosteroids (GINA)
Key exclusion criteria (4 listed)
- viral/fungal/bacterial infection +fever (<1 month)
- asthma exacerbation (<3 months)
- other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
- cardiac patients using beta-blockers
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 |
|---|---|---|
| MontelukastMontelukast, 10 mg | Drug | Montelukast |
| long acting beta2 mimeticICS+long acting beta2 agonist: twice daily | Drug | long-acting beta2-mimetic |
Primary outcome
sputum cytokine mRNA
Time frame: 8 weeks
1 secondary outcome
responsiveness to the medication
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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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 Montelukast and long acting beta2 mimetic in people with Asthmatic Patients, 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 4 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: stopped early, as of the sponsor's last update on 23 Oct 2014. 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 was stopped early (reason given: A lot of patients recruited in our center were already on montelukast treatment. It was not possible to recruit sufficient patients for the 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 (time frame: 8 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 23 Oct 2014.