CompletedPhase 2

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

44 participantsStarted 2006-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

decrease in oral corticosteroid therapy (weaning extent)

Timeframe: 16 weeks

Trial details

NCT IDNCT00842270

SponsorAB Science

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07

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