Status:
COMPLETED
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
Lead Sponsor:
AB Science
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 eosinophi...
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...
Eligibility Criteria
Inclusion
- Main inclusion criteria include:
- Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combination therapy.
- Patient with elevated eosinophil level related to asthma at baseline: ≥0.15 K/uL or patient with eosinophil level ≥0.15 K/uL related to asthma demonstrated in the year prior to screening
- Non-smoker patient for at least one year and with a prior tobacco consumption \<10 packs/year
- Main exclusion criteria include:
- Female patient who is pregnant or lactating
- Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
- Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
- Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
- Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
- Patient with active lung disease other than asthma (e.g. chronic bronchitis)
Exclusion
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT03771040
Start Date
December 1 2016
End Date
September 1 2020
Last Update
December 8 2020
Active Locations (5)
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1
Centro Respiratorio Quilmes
Buenos Aires, Argentina
2
Sarawak General Hospital
Kuching, Malaysia, 93586
3
Clínica Universidad de los Andes
Miraflores, Peru
4
The Philippine Heart Center
Quezon City, Philippines