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

Asthma Clinical Trial

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

Status Completed

Clinical 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, rescue medication intake, respiratory function)

• the pharmacokinetic profile of AB1010

• clinical and biological safety parameters

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Asthma

• NCT number: NCT00842270
• Study type: Interventional
• Source: AB Science
• Status: Completed
• Phase: Phase 2
• Start date: January 2006