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: 16.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2010-020803-63-ES
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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:
obaseline FEV1 ? 35 to < 80% of the predicted normal value, demonstrated at least 6 hours after short-acting ?-2-agonist or 12 hours after long-acting ?-2-agonist
oat least 2 asthma exacerbations within one year prior to screening visit including one severe asthma exacerbation as per protocol definition
ouncontrolled asthma as defined as two or more of the following features within the week prior to screening visit (ACQ items)
Daytime symptomsMore than twice/week
Limitations of activities symptomsAny
Nocturnal symptoms/awakening Any
Need for reliever/rescue treatmentMore 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 < 10 packs/year
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 ? 2.5x ULN
?Bilirubin ? 1.5x ULN
?Creatinine clearance ? 50 mL/min (Cockcroft and Gault formula)
?Albumin > 1 LLN
?Urea ? 1.5 x ULN
?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 Body Mass Index (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 the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
11.Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 (atrio-ventricular 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 < 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
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