Clinical Trials List
2013-06-21 - 2014-04-30
Phase III
Terminated5
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
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Trial Applicant
ClinActis Pte Ltd
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Sponsor
AB Science
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wei- Chang Huang Division of Thoracic Medicine
- 王振宇 Division of General Internal Medicine
- Ming -Cheng Chan Division of Thoracic Medicine
- 覃俊士 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chau-Chyun Sheu Division of Geriatrics
- 王程遠 Division of Geriatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Severe asthma exacerbation rate [ Time Frame: 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 Outcome Measures :
Asthma exacerbation rate [ Time Frame: 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 [ Time Frame: 36 weeks ]
Asthma Control Questionnaire (ACQ) Score
Inclution 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
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
The Estimated Number of Participants
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Taiwan
20 participants
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Global
300 participants
