Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
NCT ID: NCT00842270
Last Updated: 2018-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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* 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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2
4,5 mg/kg/day
AB1010
4,5 mg/kg/day
3
6 mg/kg/day
AB1010
6 mg/kg/day
4
matching placebo for AB1010 3, 4,5 and 6 mg/kg/day
placebo
matching placebo to AB1010 dosages
1
AB1010 3 mg/kg/day
AB1010
3 mg/kg/day
Interventions
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AB1010
3 mg/kg/day
AB1010
4,5 mg/kg/day
AB1010
6 mg/kg/day
placebo
matching placebo to AB1010 dosages
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.
18 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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References
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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.
Humbert 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.
Other Identifiers
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AB04026
Identifier Type: -
Identifier Source: org_study_id
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