NCT00901368已完成4 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 4
- 主要终点
- Pre-dose morning FEV1 measured at clinic visit 5
研究概览
简要总结
Double blind, multinational, multicentre, randomised, 2 arm parallel group study
详细描述
Aim of the present investigation is to demonstrate the clinical equivalence between fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining the same asthma control in patients adequately controlled with fluticasone plus salmeterol at the above mentioned daily dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
- •Written informed consent obtained
- •Adult male and female (≥18 and ≤65 years)
- •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)
- •Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for ≥ 4 weeks
- •A co-operative attitude and ability to correctly use the device and to complete the diary cards.
排除标准
- •Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following criteria:
- •Inability to carry out pulmonary function testing;
- •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;
- •History of near fatal asthma;
- •Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
- •Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
- •Patients treated with long-acting β2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
- •Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
- •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;
- •Patients with a serum potassium value ≤ 3.5 mEq/L
- •Patients with QTc interval (Bazett's formula) higher than 450 msec at screening visit 1;
- •Cancer or any chronic diseases with prognosis < 2 years;
- •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
- •Significant alcohol consumption or drug abuse;
- •Patients treated with beta-blockers as regular use;
- •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
- •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 with asthma exacerbations during the run-in period will also be excluded from the study.
研究组 & 干预措施
1
Experimental
CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily)
干预措施: FOSTER (Drug)
2
Active Comparator
Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily)
干预措施: Seretide (Drug)
结局指标
主要结局
Pre-dose morning FEV1 measured at clinic visit 5
时间窗: 12-week treatment
次要结局
- FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5(12-week treatment)
- Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%)(12-week treatment)
- ACQ score at baseline and at the end of treatment period(12-week treatment)
- Use of rescue medication(12-week treatment)
- Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007(12-week treatment)
- Days without asthma symptoms (%), days without use of rescue medication (%) and daily asthma symptoms' score from diary cards(12-week treatment)
- Pharmacoeconomic analyses assessing differences in direct medical costs (healthcare perspective) and in both direct healthcare and indirect costs (societal perspective).(12-week treatment)
- Adverse events and adverse drug reactions,ECG ,Vital signs, Haematology/blood chemistry tests, OUCC ratio in a in a subgroup of 15% of patients(12-week treatment)
研究者
研究点 (4)
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