A prospective, multicentre, randomised, double-blind, placebo-controlled, phase 2a study to compare the efficacy and the safety of 24-week treatment with masitinib versus placebo in patients with severe Chronic Obstructive Pulmonary Disease (COPD)

Phase 1

• Conditions: Patients with severe COPD; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005586-13-ES
• Lead Sponsor: AB SCIENCE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patient with history of chronic obstructive pulmonary disease for at least 12 months prior to screening visit (ATS/ERS 2005) and chronic productive cough for 3 months in each of the 2 years prior to screening visit (if other causes of productive cough have been excluded), and present during the 4 weeks preceding screening.
2.Patient with at least one exacerbation during the preceding year.
3.Patient with FEV1/FVC ratio (post-bronchodilator) ? 70%.
4.Patient with FEV1 (post-bronchodilator) between ? 30 % and ? 50 % of predicted value
5.Patient pre-treated with adequate and stable symptomatic treatment for at least 3 months prior to screening visit.
6.Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
7.Patient with normal organ function defined as:
?absolute neutrophils count (ANC) ? 2.0 x 109/L,
?haemoglobin ? 10 g/dL
?platelets (PTL) ? 100 x 109/L
?AST/ALT ? 3x ULN
?bilirubin ? 1.5x ULN
?creatinin clearance ? 60 mL/min
?albumin > 1 x LLN
?Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ? 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours.
8.Male or female patient, aged 40 to 75 years inclusive, weight > 50 kg and BMI between 18 and 35 kg/m²
9.Man and woman of child bearing potential, 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.
10.Female patient of childbearing potential must have a negative pregnancy test at screening and baseline
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.
13.Patient able to understand, sign, and date the written voluntary 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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Pregnant, or nursing female patient
2.Patient experiencing COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the screening visit.
3.Patient with lower respiratory tract infection not resolved 4 weeks prior to the screening visit.
4.Patient with asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis).
5.Patient currently participating in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the screening visit.
6.Patients with known alpha-1-antitrypsin deficiency.
7.Patient with clinically significant cardiopulmonary abnormalities (diagnosed clinically or by X-ray / CT-scan / ECG) that are not related to COPD and that require further evaluation.
8.Patient who had major surgery within 2 weeks prior to screening visit
9.Patient presenting with cardiac disorders defined by at least one of the following conditions:
?Patient with recent cardiac history (within 6 months) of:
-Acute coronary syndrome
-Acute heart failure (class III or IV of the NYHA classification)
-Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
?Patient with cardiac failure class III or IV of the NYHA classification
?Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
?Syncope without known aetiology within 3 months
?Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
10.Patient with:
?Life expectancy < 6 months
?< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ
?Any severe and/or uncontrolled medical condition
?Patient with an active infection (Human immunodeficiency virus infection and/or hepatitis B or C infection, tuberculosis...)
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.Treatment with any investigational agent within 4 weeks prior baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified