NCT00842270

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: AB Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	AB1010	3 mg/kg/day
DRUG	AB1010	4,5 mg/kg/day
DRUG	AB1010	6 mg/kg/day
DRUG	placebo	matching placebo to AB1010 dosages

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-07-01
• First posted: 2009-02-12
• Last updated: 2018-12-11