Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

Overview

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

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

Interventions

Eligibility

Outcomes