AsthmaPhase 2NCT00842270
Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
A Phase 2 study testing AB1010 in people with Asthma, run by AB Science.
Trial summary
The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on : the decrease in corticosteroid therapy the asthma control improvement (symptomatic scores… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- AB1010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
- Disease duration > 1 year.
- Stable disease with no exacerbation episode for at least one month before inclusion.
- Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
- Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.
Who cannot join
- Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
- History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :
- the decrease in corticosteroid therapy
- the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
- the pharmacokinetic profile of AB1010
- clinical and biological safety parameters
Read the detailed description
This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.
The study treatment is administered for 16 weeks:
- the first 4 weeks are a run-in period during which corticosteroids remain stable;
- during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
- the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.
- Conditions
- Asthma
- Being tested
- AB1010, placebo
- Keywords
- severe asthma, corticosteroids dependent, asthma exacerbation, weaning, tyrosine kinase inhibitor, severe persistent corticosteroid dependent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB1010Drug
Also called masitinib
3 mg/kg/day
AB1010Drug
Also called masitinib
4,5 mg/kg/day
AB1010Drug
Also called masitinib
6 mg/kg/day
placeboDrug
matching placebo to AB1010 dosages
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | 4,5 mg/kg/day Receives: Drug: AB1010 |
| 3 | Experimental | 6 mg/kg/day Receives: Drug: AB1010 |
| 4 | Placebo comparator | matching placebo for AB1010 3, 4,5 and 6 mg/kg/day Receives: Drug: placebo |
| 1 | Experimental | AB1010 3 mg/kg/day Receives: Drug: AB1010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in oral corticosteroid therapy (weaning extent)
Measured: 16 weeks
Secondary outcomes (2)
asthma control improvement
Measured: 16 weeks
asthma exacerbation rate
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2006
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842270
- Sponsor's protocol ID
- AB04026
- Status last verified
- Dec 2018
- First submitted
- 11 Feb 2009
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee-Fowler TM, Guntur V, Dodam J, Cohn LA, DeClue AE, Reinero CR. The tyrosine kinase inhibitor masitinib blunts airway inflammation and improves associated lung mechanics in a feline model of chronic allergic asthma. Int Arch Allergy Immunol. 2012;158(4):369-74. doi: 10.1159/000335122. Epub 2012 Apr 4.
PubMed 22487554Humbert M, de Blay F, Garcia G, Prud'homme A, Leroyer C, Magnan A, Tunon-de-Lara JM, Pison C, Aubier M, Charpin D, Vachier I, Purohit A, Gineste P, Bader T, Moussy A, Hermine O, Chanez P. Masitinib, a c-kit/PDGF receptor tyrosine kinase inhibitor, improves disease control in severe corticosteroid-dependent asthmatics. Allergy. 2009 Aug;64(8):1194-201. doi: 10.1111/j.1398-9995.2009.02122.x.
PubMed 19614621
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
- ClinicalTrials.gov ID
- NCT00842270
- Acronym / sponsor ID
- AB04026
- Conditions
- Asthma
- Keywords
- severe asthma, corticosteroids dependent, asthma exacerbation, weaning, tyrosine kinase inhibitor, severe persistent corticosteroid dependent asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AB ScienceIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- First posted
- 12 Feb 2009 (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 aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :
- the decrease in corticosteroid therapy
- the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
- the pharmacokinetic profile of AB1010
- clinical and biological safety parameters
Detailed description
This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.
The study treatment is administered for 16 weeks:
- the first 4 weeks are a run-in period during which corticosteroids remain stable;
- during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
- the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: AB10104,5 mg/kg/day |
| 3 | Experimental | Drug: AB10106 mg/kg/day |
| 4 | Placebo comparator | Drug: placebomatching placebo for AB1010 3, 4,5 and 6 mg/kg/day |
| 1 | Experimental | Drug: AB1010AB1010 3 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
- Disease duration > 1 year.
- Stable disease with no exacerbation episode for at least one month before inclusion.
- Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
- Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.
Key exclusion criteria (2 listed)
- Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
- History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.
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 |
|---|---|---|
| AB1010Also: masitinib3 mg/kg/day | Drug | 1 |
| AB1010Also: masitinib4,5 mg/kg/day | Drug | 2 |
| AB1010Also: masitinib6 mg/kg/day | Drug | 3 |
| placebomatching placebo to AB1010 dosages | Drug | 4 |
Primary outcome
decrease in oral corticosteroid therapy (weaning extent)
Time frame: 16 weeks
2 secondary outcomes
asthma control improvement
Time frame: 16 weeks
asthma exacerbation rate
Time frame: 16 weeks
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 11 Dec 2018.
- Background: PubMed 22487554Lee-Fowler TM, Guntur V, Dodam J, Cohn LA, DeClue AE, Reinero CR. The tyrosine kinase inhibitor masitinib blunts airway inflammation and improves associated lung mechanics in a feline model of chronic allergic asthma. Int Arch Allergy Immunol. 2012;158(4):369-74. doi: 10.1159/000335122. Epub 2012 Apr 4.
- Results publication: PubMed 19614621Humbert M, de Blay F, Garcia G, Prud'homme A, Leroyer C, Magnan A, Tunon-de-Lara JM, Pison C, Aubier M, Charpin D, Vachier I, Purohit A, Gineste P, Bader T, Moussy A, Hermine O, Chanez P. Masitinib, a c-kit/PDGF receptor tyrosine kinase inhibitor, improves disease control in severe corticosteroid-dependent asthmatics. Allergy. 2009 Aug;64(8):1194-201. doi: 10.1111/j.1398-9995.2009.02122.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AB1010 in people with Asthma, run by AB Science.
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 5 inclusion and 2 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
decrease in oral corticosteroid therapy (weaning extent) (time frame: 16 weeks). 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 NCT00842270, which also lists 2 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 11 Dec 2018.