NCT00413387已完成3 期
Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 µg + Formoterol 6 µg) pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler® (Symbicort®) in the 12-Week Treatment of Adult Patients With Moderate to Severe Persistent Asthma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 13
- 主要终点
- Morning Peak Expiratory Flow (PEF) daily measured by patients.
研究概览
简要总结
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.
详细描述
Asthma is a chronic disease that is estimated to affect over 25 million people both in the U.S. and in Europe (i.e. approximately 10% of the total population). Pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyper-reactivity. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (i.e. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in forms of bronchodilators (i.e. β-adrenergic agonists, anticholinergics). In patients treated with inhaled glucocorticosteroids whose asthma is not fully controlled, national and international guidelines recommend a stepwise approach. Recent evidence-based clinical trials show that the addition of a LABA to inhaled glucocorticosteroids is more beneficial in terms of asthma control than increasing the dose of corticosteroids alone.
COMPARISONS: CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg+ FORMOTEROL 6 µg) pMDI via HFA-134a compared to SYMBICORT (BUDESONIDE 160 µg + FORMOTEROL 4,5 µg).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of moderate to severe persistent asthma for at least 6 months, according to GINA revised version 2002 guidelines:
- •Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) > 50% and < 80% of the predicted normal;
- •Asthma not adequately controlled with the current therapies, defined as presence of daily asthma symptoms > once a week and night-time asthma symptoms > twice a month, and daily use of short-acting β2-agonists. These findings are to be based on recent medical history and are to be confirmed in the 2-week run-in period.
- •Treatment with inhaled corticosteroids at a daily dose ≤ 1000 μg of BDP or equivalent. The daily dose of inhaled corticosteroids taken at visit 1 will be assessed taking into account the following ratios between the doses of the different steroids: fluticasone propionate : BDP CFC = 1 : 2; budesonide : BDP CFC = 4 : 5; flunisolide : BDP CFC = 1 :
- •The ratios between inhaled steroids are irrespective of the formulations (i.e. spray aerosol or powder) used. When BDP is given in the new extra-fine HFA-134a formulation (as QVAR®, 3M Healthcare), the ratio with BDP CFC is set as 2 :
- •Therefore, the maximum allowed daily dose of inhaled corticosteroids at study entry will be: budesonide 800 μg, fluticasone propionate 500 μg, flunisolide 1000 μg, BDP 1000 mcg, BDP HFA extra-fine 400 μg.
- •Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200mL) from baseline value in the measurement of FEV1 30 minutes following 2 puffs (2 x 100 µg) of inhaled salbutamol administered via pMDI. The reversibility test can be avoided in patients having a documented positive response in the previous 6 months.
- •A co-operative attitude and ability to be trained to correctly use the metered dose inhalers and to complete the diary cards.
- •Written informed consent obtained.
- •At the end of the 2-week run-in period, the presence of daily asthma symptoms (of at least mild intensity) and nighttime asthma symptom (of at least mild intensity) > once a week, as well as of daily use of relief salbutamol is to be confirmed by reviewing the diary cards for run-in
排除标准
- •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 (30);
- •History of near fatal asthma;
- •Evidence of severe asthma exacerbation or 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 long-acting β2-agonists, anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks;
- •Patients who have changed their dose of inhaled corticosteroids during the previous 4 weeks, or treatment with inhaled corticosteroids at a daily dose > 1000 μg of BDP or equivalent (except for extra-fine formulations, see inclusion criteria);
- •Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day;
- •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;
- •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). A pregnancy test is to be carried out in women of a fertile age.
- •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 PEFR (L/sec) measured at the clinics at the end of the run-in period > 15% in respect of values 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.
研究组 & 干预措施
1
Experimental
chf1535
干预措施: beclomethasone dipropionate plus formoterol fumarate combination (Drug)
2
Active Comparator
Symbicort
干预措施: budesonide plus formoterol combination (Drug)
结局指标
主要结局
Morning Peak Expiratory Flow (PEF) daily measured by patients.
时间窗: morning approximately 8:00
次要结局
- Use of relief salbutamol measured by patients daily.(daily)
- Evening PEF measured by patients daily.(evening approximately 20:00)
- FEV1 measured by patients daily.(morning and evening)
- Standard pulmonary function tests measured at clinics at 2, 4, 8 and 12 weeks.(morning before drug intake)
- Change in FEV1 and PEF from pre-dose to 5, 15, 30 and 60 minutes after study drug intake at week 0 and 12.(morning post drug intake)
- Symptoms scores measured by patients daily.(morning and evening)
- symptoms'free days measured by patients daily.(daily)
- Frequency of asthma exacerbations evaluated at 2, 4, 8 and 12 weeks.(morning of the visits retrospective assessment)
- Adverse event and adverse drug reaction daily.(morning of visits retrospective assesment)
- ECG (with QTc interval)at 0 and 12 weeks.(morning of start and end of treatment visits)
- Vital signs (heart rate and blood pressure) at 2, 4, 8 and 12 weeks(morning of visits)
- Use of relief salbutamol.(daily)
- Frequency of asthma exacerbations.(at visits)
研究者
研究点 (13)
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