A clinical study of Masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Phase 3

Suspended

• Conditions: Health Condition 1: null- Severe Persistent Asthma

• Registration Number: CTRI/2011/11/002122
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 300

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 < 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 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

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 < 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

14. Patient with known hypersensitivity to Cetirizine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified