EUCTR2008-003740-11-DE进行中（未招募）不适用
A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS. - FACTO study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 452
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
- •1.Written informed consent obtained
- •2.Adult male and female (=18 and =65 years)
- •3.Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry:
- •-no daytime symptoms (twice or less/week)
- •-no limitations of activities
- •-no nocturnal symptoms/awakenings
- •-no need for reliever/rescue medications (twice or less/week)
- •-lung function (FEV1) = 80% predicted or personal best (if known)
- •4.Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for = 4 weeks
- •5.A co-operative attitude and ability to correctly use the device and to complete 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
- •1.Inability to carry out pulmonary function testing;
- •2.Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
- •3.History of near fatal asthma;
- •4.Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
- •5.Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
- •6.Patients treated with long-acting ß2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
- •7.Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
- •8.Clinically significant or unstable concurrent disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion;
- •9.Patients with a serum potassium value = 3.5 mEq/L
- •10.Patients with QTc interval (Bazett’s formula) higher than 450 msec at screening visit 1;
- •11.Cancer or any chronic diseases with prognosis < 2 years;
- •12.Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening
- •13.Significant alcohol consumption or drug abuse;
- •14.Patients treated with beta-blockers as regular use;
- •15.Patients treated with monoamine oxidase inhibitor, tricyclic antidepressants and Selective Serotonin Re-uptake Inhibitors (SSRIs), unless already taken at stable doses at the screening visit
- •16.Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
- •17.Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •18.Patients who received any investigational new drug within the last 12 weeks;
- •19.Patients with asthma exacerbations during the run-in period will also be excluded from the study.
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