Asthma
Conditions
Keywords
severe persistent asthma, tyrosine kinase inhibitor
Brief summary
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.
Detailed description
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.
Interventions
DRUGMasitinib
6 mg/kg/day
DRUGPlacebo
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 75 Years
Healthy volunteers
No
Inclusion criteria
Main inclusion criteria: 1. Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit 2. Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening 3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit 4. Non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year Main
Exclusion criteria
1. Patient with active lung disease other than asthma (e.g. chronic bronchitis) 2. Female patient who is pregnant or lactating 3. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control 4. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe asthma exacerbation rate | Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months | The number of severe asthma exacerbations over time frame of outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma exacerbation rate | Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months | The number of asthma exacerbations over time frame of outcome measure |
| ACQ Score | 36 weeks | Asthma Control Questionnaire (ACQ) Score |
Countries
Bulgaria, Czechia, France, Hungary, India, Spain
Outcome results
None listed