EUCTR2006-005349-13-BG进行中（未招募）不适用
PROSPECTIVE, RANDOMIZED, OPEN-LABEL, MULTICENTRE, ACTIVE DRUG CONTROLLED, PARALLEL GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE 400 MCG + FORMOTEROL 24 MCG PMDI VIA HFA-134A (FOSTER™) VS. FLUTICASONE PROPIONATE 500 MCG + SALMETEROL XINAFOATE 100 MCG DPI (SERETIDE DISKUS®) IN THE 6 MONTHS STEP DOWN TREATMENT OF ADULT PATIENTS WITH CONTROLLED ASTHMA - FORTE
Chiesi Farmaceutici SpA0 个研究点目标入组 450 人开始时间: 2008年12月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- •- Age between 18 and 65 years, limits included;
- •- Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2005 guidelines and considering current treatment;
- •- Male or female;
- •- Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) ³ 80% of the predicted normal value;
- •- Treated with fluticasone 1000 mcg + salmeterol 100 mcg daily for at least 4 weeks at a stable dose;
- •- Reporting no nocturnal symptoms or awakenings, no exacerbations, no limitations of activities, symptoms in = 2 days and use of rescue medication = 2 days per week, in the last 4 weeks;
- •- Exhibiting a co-operative attitude and ability to be trained to correctly use the study devices and to complete the diary cards.
- •At the end of run in period (Week 8+0; Visit 3), patients will be recruited into the treatment period and
- •randomized to treatment if they meet the following criterion:
- •- asthma is controlled 1 in each of the last 4 weeks of run-in (no nocturnal symptoms or awakenings; no exacerbations; no limitations of activities; symptoms in £2 days; use of rescue medication = 2 days; morning PEF = 80% of predicted in every day) confirmed by reviewing the diary cards.
- •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) as defined by the NHLBI/WHO's GOLD guidelines;4
- •- Current smokers or recent (less than one year) ex-smokers with a smoking history of = 10 pack/years;
- •- History of near fatal asthma;
- •- Evidence of symptomatic infection of the airways in the previous 8 weeks;
- •- Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
- •- Patients treated with anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks;
- •- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
- •- Diabetes mellitus;
- •- PTCA or 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;
- •- Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradicardia (£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 of childbearing potential, who are not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential;
- •- 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 run in period (Week 8+0; Visit 3), patients will not be randomized to treatment if they do
- •not completely meet the definition of controlled asthma. These subjects will be
- •considered screening failures and will not count against the planned number to be recruited.
研究者
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