drugset / Trial / NCT00842270
Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
RandomizedParallel-groupQuadruple-blindTreatment
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, rescue medication intake, respiratory function) * the pharmacokinetic profile of AB1010 * clinical and biological safety parameters
Timeline
- Start
- 2006-01
- Primary completion
- 2007-07
- Completion
- —
Publications
- Background 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Masitinib | Small molecule | 3 mg/kg | Oral |
| Subject | Masitinib | Small molecule | 4.5 mg/kg | Oral |
| Subject | Masitinib | Small molecule | 6 mg/kg | Oral |