Back to resultsMasitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Masitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring severe persistent asthma, tyrosine kinase inhibitor
Eligibility Criteria
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
Sites / Locations
- Dr. Georgi Stranski University Hospital
- Hospital Polyclinic Melnik
- Hospital La Cavale Blanche
- l'Hopital Albert Calmette
- l'Hopital de la Croix Rousse
- University of Debrecen Medical and Health Science Center
- King George Hospital
- Hospital Universitario Doctor Peset
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Masitinib as add-on to oral corticosteroids
Placebo as add-on to oral corticosteroids
Arm Description
Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Outcomes
Primary Outcome Measures
Severe asthma exacerbation rate
The number of severe asthma exacerbations over time frame of outcome measure
Secondary Outcome Measures
Asthma exacerbation rate
The number of asthma exacerbations over time frame of outcome measure
ACQ Score
Asthma Control Questionnaire (ACQ) Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01449162
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Science
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
severe persistent asthma, tyrosine kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masitinib as add-on to oral corticosteroids
Arm Type
Experimental
Arm Description
Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Arm Title
Placebo as add-on to oral corticosteroids
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Intervention Type
Drug
Intervention Name(s)
Masitinib
Other Intervention Name(s)
AB1010
Intervention Description
6 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Severe asthma exacerbation rate
Description
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
Secondary Outcome Measure Information:
Title
Asthma exacerbation rate
Description
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
Title
ACQ Score
Description
Asthma Control Questionnaire (ACQ) Score
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lavinia Davidescu, MD, PhD
Organizational Affiliation
University of Medicine and Pharmacy Oradea, Oradea, Romania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Georgi Stranski University Hospital
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Hospital Polyclinic Melnik
City
Mělník
Country
Czechia
Facility Name
Hospital La Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
l'Hopital Albert Calmette
City
Lille
Country
France
Facility Name
l'Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
University of Debrecen Medical and Health Science Center
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
King George Hospital
City
Hyderabad
ZIP/Postal Code
500068
Country
India
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
12. IPD Sharing Statement
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Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids
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