Health Condition 1: null- Severe Persistent Asthma
Conditions
Interventions
Intervention1: Masitinib: 100 mg and 200 mg tablets daily dose of 6 mg/kg for 36 weeks of treatment period, upon investigators discretion responders might enter into extension phase during which patie
Sponsors
AB Science
Maya Clinicals Drug Development Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with Severe Persistent Asthma and already treated with oral corticosteroids at a minimal daily dose of 5 mg prednisone or equivalent for at least 3 months prior to screening visit 2. Patient with history of asthma >= 1 year prior to screening visit who also meet the following criteria: o baseline FEV1 ³ 35 to £ 80% of the predicted normal value, demonstrated at least 6 hours after short-acting b-2-agonist or 12 hours after long-acting b-2-agonist o at least 2 asthma exacerbations within one year prior to screening visit including one severe asthma exacerbation as per protocol definition o uncontrolled asthma as defined as two or more of the following features within the week prior to screening visit (ACQ items) Daytime symptoms More than twice/week Limitations of activities symptoms Any Nocturnal symptoms/awakening Any Need for reliever/rescue treatment More than twice/week 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 one year and with a prior tobacco consumption 5. Patient with normal organ function defined as: · Absolute neutrophil count (ANC) >= 2.0 x 109/L · Haemoglobin >= 10 g/dL · Platelets (PTL) >= 100 x 109/L · AST/ALT · Bilirubin · Creatinine clearance >= 50 mL/min (Cockcroft and Gault formula) · Albumin > 1 LLN · Urea · Proteinuria = 30 mg/dL, 24 hours proteinuria 6. Male or female patient older than 18 years 7. Patient weight > 45 kg and BMI > 18 kg/m² 8. Male or female patient of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake 9. Patient able and willing to comply with study procedures as per protocol 10. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
Exclusion criteria
Exclusion criteria: 1. Female patient who is pregnant or lactating 2. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control 3. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit 4. Patient presenting with cardiac disorders defined by at least one of the following conditions will be excluded: a. Patient with recent cardiac history (within 6 months) of: i. Acute coronary syndrome ii. Acute heart failure (class III or IV of the NYHA classification) iii. Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) b. Patient with cardiac failure class III or IV of the NYHA classification c. Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular block 2 and 3, sino-atrial block) d. Syncope without known aetiology within 3 months e. Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 5. Patient with active lung disease other than asthma (e.g. chronic bronchitis) 6. Patient who had a major surgery within 2 weeks prior to screening visit 7. Patient with life expectancy 8. Patient with history of primary malignancy carcinoma in situ 9. Patient with any severe and/or uncontrolled medical condition 10. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection 11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 12. Patient with inadequate wash-out time at the screening visit: Wash-out time for prohibited concomitant asthma medications: Treatment with the following non-steroidal controllers has to be stopped about 24 h prior to screening visit: sustained-release theophylline, leukotriene antagonists, lipoxygenase inhibitors, inhaled anticholinergics, oral beta2-agonists, inhaled disodium cromoglycate, inhaled nedocromil. Wash-out time for allowed concomitant asthma medications · Long acting Beta agonists (12h prior to screening visit) · Short acting agonists (6h prior to screening visit) 13. Patient treated with prohibited medications 14. Patient with known hypersensitivity to Cetirizine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma exacerbation rate (severe and moderate exacerbations) adjusted on the available person-time (time to end of treatment)Timepoint: At week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| . ACQ Score. · Moderate and severe asthma exacerbation rate. · Severe asthma exacerbation rate. · Time to first asthma exacerbation (severe or moderate) · Percentage of patient experiencing at least one exacerbation. · Asthma symptom score at all time points. ·FEV1, FVC, Forced Expiratory Flow between 25-75% of FVC (FEF25-75). · Morning and evening PEFR· Use of rescue medication for asthma. · AQLQ score at each visit.Timepoint: At week 12, 20, 28 and 36 | — |
Countries
Bulgaria, Czech Republic, France, Hungary, India, Thailand
Contacts
Public ContactDr Sudhir Kumar
Maya Clinicals Drug Development Pvt. Ltd.
Outcome results
None listed