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

AB Science

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: AB1010; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00842270

AB04026

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 4 patient groups, including a placebo group

2

Experimental group

Description:

4,5 mg/kg/day

Treatment:

Drug: AB1010

Drug: AB1010

Drug: AB1010

3

Experimental group

Description:

6 mg/kg/day

Treatment:

Drug: AB1010

Drug: AB1010

Drug: AB1010

4

Placebo Comparator group

Description:

matching placebo for AB1010 3, 4,5 and 6 mg/kg/day

Treatment:

Drug: placebo

1

Experimental group

Description:

AB1010 3 mg/kg/day

Treatment:

Drug: AB1010

Drug: AB1010

Drug: AB1010