EUCTR2007-002816-25-ES进行中（未招募）1 期
Multicentre, multinational, randomised, double blind, double dummy, active drug controlled, parallel group study design clinical trial of the efficacy and tolerability of beclomethasone dipropionate 250 mcg plus salbutamol 100 mcg in HFA pMDI fixed combination vs. beclomethasone dipropionate 250 mcg plus salbutamol 100 mcg in CFC pMDI (Clenil® Compositum 250) fixed combination in a 12-week treatment period of adult patients with uncontrolled asthma.
Chiesi Farmaceutici SpA0 个研究点目标入组 282 人开始时间: 2010年3月9日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 282
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent obtained;
- •- Male or female out-patients aged = 18 and < 65 years;
- •- Uncontrolled asthma defined according to the GINA 2006 Classification of Levels of Asthma Control” (to be confirmed in the 2-weeks run-in period);
- •- Forced expiratory volume in the first second (FEV1) = 60% and < 80% of the predicted normal value;
- •- Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200 mL) from pre-bronchodilator value in the measurement of FEV1 30 minutes following 4 puffs (4 x 100 µg) of inhaled salbutamol administered via pMDI;
- •- Non-smokers or ex-smokers with a cumulative tobacco exposure less than 5 pack-years and who have stopped smoking since more than 1 year;
- •- A co-operative attitude and ability to be trained to correctly use the pMDIs;
- •- At the end of the 2-week run-in period, the condition of uncontrolled asthma is to be confirmed by reviewing the diary cards for run-in
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Inability to carry out pulmonary function testing;
- •- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
- •- History of near fatal asthma;
- •- Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks;
- •- Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
- •- Patients who have been treated with an inhaled corticosteroid in the previous 4 weeks;
- •- Patients who have been treated with nebulized, oral, intravenous or intramuscular corticosteroids in the past 8 weeks or depot injectable corticosteroids in the past 12 weeks;
- •- Patients who have been treated with a long-acting ß2-agonist (LABA) in the past 2 weeks;
- •- Patients who have been treated with an oral ß2-agonist in the past 48 hours;
- •- Patients who have been treated with a short-acting ß2-agonist (SABA) in the past 6 hours;
- •- Patients who have been treated with nebulized bronchodilators in the past 2 weeks;
- •- Patients who have been treated with anticholinergic medications (by any route) in the past 2 weeks;
- •- Patients who have been treated with a xanthine derivative (by any route) in the past 4 weeks;
- •- Patients who have been treated with an inhaled cromone or a leukotriene modifier in the past 4 weeks;
- •- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
- •- Diabetes mellitus;
- •- Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months;
- •- Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females;
- •- Patients with a serum potassium value = 3.5 mEq/L (or 3.5 mmol/L) and/or fasting serum glucose value = 140 mg/dL (or 7.77 mmol/L);
- •- Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradycardia (= 55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree;
- •- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases;
- •- Cancer or any chronic diseases with prognosis < 2 years;
- •- Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization);
- •- History of alcohol or drug abuse;
- •- Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use;
- •- Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
- •- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •- Patients who received any investigational new drug within the last 12 weeks;
- •- Patients who have been previously enrolled in this study;
- •- At the end of the run-in period, patients will not be admitted to the treatment period in the case of an increase of FEV1 measured at the clinics at the end of the run-in period = 15% in respect of the pre-bronchodilator value measured at the start of the run-in period;
- •- Patients with asthma exacerbations during the run-in period will also be excluded from the study;
研究者
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