Clinical trial NCT00842270: Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: severe asthma
corticosteroids dependent
asthma exacerbation
weaning
tyrosine kinase inhibitor
severe persistent corticosteroid dependent asthma
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: decrease in oral corticosteroid therapy (weaning extent)
timeFrame: 16 weeks
Secondary outcomes:
measure: asthma control improvement
timeFrame: 16 weeks
measure: asthma exacerbation rate
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Lee-Fowler TM, Guntur V, Dodam J, Cohn LA, DeClue AE, Reinero CR. The tyrosine kinase inhibitor masitinib blunts airway inflammation and improves associated lung mechanics in a feline model of chronic allergic asthma. Int Arch Allergy Immunol. 2012;158(4):369-74. doi: 10.1159/000335122. Epub 2012 Apr 4.
citation: Humbert M, de Blay F, Garcia G, Prud'homme A, Leroyer C, Magnan A, Tunon-de-Lara JM, Pison C, Aubier M, Charpin D, Vachier I, Purohit A, Gineste P, Bader T, Moussy A, Hermine O, Chanez P. Masitinib, a c-kit/PDGF receptor tyrosine kinase inhibitor, improves disease control in severe corticosteroid-dependent asthmatics. Allergy. 2009 Aug;64(8):1194-201. doi: 10.1111/j.1398-9995.2009.02122.x.