Evalution of efficacy of masitinib in patients with severe asthma dependent to corticosteroids

Phase 1

• Conditions: Severe Persistent Asthma; MedDRA version: 19.0Level: 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-CZ
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-22
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

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

Inclusion Criteria

1.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
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:
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

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 and ALT = 3 x ULN
•Bilirubin = 1.5x ULN
•Creatinine clearance = 60 mL/min (Cockcroft and Gault formula)
•Albumin > 1 x LLN
•Proteinuria < 30 mg/dL (1+) on the dipstick. In case of proteinuria = 30 mg/dL, 24 hours proteinuria must be < 1.5 g/24 hours
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 has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.

•Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake OR who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.

•Highly effective methods of contraception include:
1) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
2) Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
4) Intrauterine device (IUD)
3) Intrauterine hormone-releasing system (IUS)
4) Bilateral tubal occlusion
5) Vasectomized male (azoospermia assessed medically)
6) Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)

Acceptable methods of contraception include:
1) Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
2) Male or female condom with or without spermicide
10.3) Cap, diaphragm or sponge with spermicideP

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
f.patients who have had allergy to any of the components of the administrated treatment in their medical history
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