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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: AB1010; Drug: placebo

• Registration Number: NCT00842270
• Lead Sponsor: AB Science

Brief 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-07
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
• 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

• Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
• History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AB1010	4,5 mg/kg/day
3	AB1010	6 mg/kg/day
4	placebo	matching placebo for AB1010 3, 4,5 and 6 mg/kg/day
1	AB1010	AB1010 3 mg/kg/day

Primary Outcome Measures

Name	Time	Method
decrease in oral corticosteroid therapy (weaning extent)	16 weeks

Secondary Outcome Measures

Name	Time	Method
asthma exacerbation rate	16 weeks
asthma control improvement	16 weeks