Asthma
Conditions
Keywords
severe asthma, corticosteroids dependent, asthma exacerbation, weaning, tyrosine kinase inhibitor, severe persistent corticosteroid dependent asthma
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.
Interventions
DRUGAB1010
3 mg/kg/day
DRUGplacebo
matching placebo to AB1010 dosages
Sponsors
AB Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| decrease in oral corticosteroid therapy (weaning extent) | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| asthma control improvement | 16 weeks |
| asthma exacerbation rate | 16 weeks |
Outcome results
None listed