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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science

Criteria

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.