Status:
COMPLETED
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Lead Sponsor:
AB Science
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- 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
- Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
- Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
- Non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year
- Main exclusion criteria:
- Patient with active lung disease other than asthma (e.g. chronic bronchitis)
- Female patient who is pregnant or lactating
- Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
- Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT01449162
Start Date
January 1 2011
End Date
November 1 2019
Last Update
February 10 2021
Active Locations (8)
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1
Dr. Georgi Stranski University Hospital
Pleven, Bulgaria, 5800
2
Hospital Polyclinic Melnik
Mělník, Czechia
3
Hospital La Cavale Blanche
Brest, France, 29609
4
l'Hopital Albert Calmette
Lille, France