The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.
Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
Dr. Georgi Stranski University Hospital
Pleven, Bulgaria
Hospital Polyclinic Melnik
Mělník, Czechia
Hospital La Cavale Blanche
Brest, France
l'Hopital Albert Calmette
Lille, France
Severe asthma exacerbation rate
The number of severe asthma exacerbations over time frame of outcome measure
Time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Asthma exacerbation rate
The number of asthma exacerbations over time frame of outcome measure
Time frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
ACQ Score
Asthma Control Questionnaire (ACQ) Score
Time frame: 36 weeks
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