Asthmatic PatientsBioSput-AirNCT01224977
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
A study testing azithromycin 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 antimicrobial therapy with potential anti-inflammatory potency 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?
- azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2011to Dec 2019
- 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
- severe asthmatics (GINA step 4 or step 5 (without anti-IgE))
Who cannot join
- viral/fungal/bacterial infection +fever (<1 month)
- asthma exacerbation (<3 months)
- other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Leuven
Leuven, Vlaams-Brabant, 3000
Sven F Seys, PhD, +32 16 346165, sven.seys@med.kuleuven.be
Dominique MA Bullens, MD, PhD, +32 16 346137, Dominique.bullens@med.kuleuven.be
About this study
The main objectives of the study are:
- To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency
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-microbial therapy with potential anti-inflammatory potency (macrolides).
- Conditions
- Asthmatic Patients
- Being tested
- azithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
azithromycin 500 mg 3/week for 3 months
| Study group | Role | What they receive |
|---|---|---|
| azithromycin | Other | Not described Receives: Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
sputum cytokine mRNA
Measured: 3 months
Secondary outcomes (1)
responsiveness to the medication
Measured: 3 months
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 startJul 2011
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01224977
- Sponsor's protocol ID
- Biomarker sputum airway study4
- Acronym
- BioSput-Air
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2010
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 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 4.
- ClinicalTrials.gov ID
- NCT01224977
- Acronym / sponsor ID
- BioSput-Air / Biomarker sputum airway study4
- Conditions
- Asthmatic Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (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 antimicrobial therapy with potential anti-inflammatory potency
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-microbial therapy with potential anti-inflammatory potency (macrolides).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azithromycin | Other | Drug: azithromycin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe asthmatics (GINA step 4 or step 5 (without anti-IgE))
Key exclusion criteria (3 listed)
- viral/fungal/bacterial infection +fever (<1 month)
- asthma exacerbation (<3 months)
- other respiratory disease (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 |
|---|---|---|
| azithromycinazithromycin 500 mg 3/week for 3 months | Drug | azithromycin |
Primary outcome
sputum cytokine mRNA
Time frame: 3 months
1 secondary outcome
responsiveness to the medication
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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 azithromycin 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 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 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sputum cytokine mRNA (time frame: 3 months). 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 13 Jul 2018.