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
- Conditions
- Severe Persistent AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-020803-63-SK
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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 = 35 to = 80% of the predicted normal value, demonstrated at least 6 hours after short-acting beta-2-agonist or 12 hours after long-acting beta-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
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 < 10 packs/year
5. Patient with normal organ function defined as:
o Absolute neutrophil count (ANC) = 2.0 x 109/L
o Haemoglobin = 10 g/dL
o Platelets (PTL) = 100 x 109/L
o AST/ALT = 2.5x ULN
o Bilirubin = 1.5x ULN
o Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
o Albumin > 1 LLN
o Urea = 1.5 x ULN
o Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
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
11. Patient affiliated to a social security regimen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.Ischemic heart disease, defined by at least one of the following conditions:
i.Medical history of ischemic heart disease
ii.Clinical symptoms of ischemic heart disease
iii.Q wave > 3 mm on the electrocardiogram
iv.ST elevation or depression > 2 mm on the electrocardiogram
v.Negative T wave in at least 2 leads of the electrocardiogram
b.Cardiac failure, defined by at least one of the following conditions:
i.Medical history of cardiac failure defined by a previous left ventricular ejection fraction = 50%
ii.Clinical symptoms of cardiac failure
iii.Current treatment for cardiac failure
iv.NT Pro-BNP = 300 pg/mL or BNP = 75 pg/mL and/or troponin T > 0.1 ng/mL or troponin I > 0.35 ng/mL
c.Conduction disorders or arrhythmia, defined by at least one of the following and confirmed by electrocardiogram:
i.Severe ventricular arrhythmia (frequent premature ventricular beats)
ii.Atrioventricular block at second or third level
iii.Left bundle branch block
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 < 6 months
8.Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical 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
RANDOMISATION CRITERIA (to be checked at W0):
1.Good study treatment (i.e. placebo) compliance (=80%) during the 2-week run-in period
2.Daily mean symptom score = 2 during the 2-week run in period
3.No asthma exacerbation (moderate or severe) during the 2-week run in period
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method