The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.
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. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
347
Centro Respiratorio Quilmes
Buenos Aires, Argentina
Sarawak General Hospital
Kuching, Malaysia
Clínica Universidad de los Andes
Miraflores, Peru
The Philippine Heart Center
Quezon City, Philippines
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
Asthma Control Questionnaire (ACQ)
Asthma Control Questionnaire (ACQ) * Type of questionnaire-description: A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. * Number of items: 7 items; 1 week recall (for items on symptoms and rescue inhaler use) * Number of domains \& categories: ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff * Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Time frame: 48 weeks
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National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine
Kiev, Ukraine