Clinical trial NCT01449162: Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Official title: A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: severe persistent asthma
tyrosine kinase inhibitor
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Severe asthma exacerbation rate
timeFrame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
Secondary outcomes:
measure: Asthma exacerbation rate
timeFrame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months
measure: ACQ Score
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Dr. Georgi Stranski University Hospital
city: Mělník
country: Czechia
facility: Hospital Polyclinic Melnik
city: Brest
country: France
facility: Hospital La Cavale Blanche
city: Lille
country: France
facility: l'Hopital Albert Calmette
city: Lyon
country: France
facility: l'Hopital de la Croix Rousse
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center
city: Hyderabad
country: India
facility: King George Hospital
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
Study officials:
affiliation: University of Medicine and Pharmacy Oradea, Oradea, Romania
name: Lavinia Davidescu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: