Evaluation of Masitinib in Severe Persistent Asthma.

• Conditions: Severe Persistent Asthma; MedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-020803-63-DE
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patient with Severe Persistent 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
2. Patient treated during at least one period of 21 days with oral corticosteroids from one year prior to screening to 3 months before screening.
3. 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 ?-2-agonist or 12 hours after long-acting ?-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 symptomsMore than twice/week
Limitations of activities symptomsAny
Nocturnal symptoms/awakening Any
Need for reliever/rescue treatment More than twice/week
4. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
5. Non-smoker patient for at least one year and with a prior tobacco consumption < 10 packs/year
6. 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 = 3 x ULN
• Bilirubin = 1.5x ULN
• Creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
• Albumin > 1 LLN
• Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours
• Patient with negative urine cytology and NMP22 protein assay
7. Male or female patient aged 18 to 75 years
8. Patient weight > 50 kg and Body Mass Index (BMI) between 18 and 35 kg/m²
9. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective 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.
10. Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug.
11. Patient able and willing to comply with study procedures as per protocol
12. 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.
13. 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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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 (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:
•Long Acting Bronchodilators (12h prior to screening visit)
•Short Acting Bronchodilators (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