EUCTR2006-006793-26-DE进行中（未招募）不适用
Randomised, double-blind, double-dummy, cross-over trial comparing salmeterol 50 µg b.i.d. via a novel DPI versus salmeterol 50 µg b.i.d. via Diskus in adult patients with persistent asthma - Inhalation Study Salmeterol DPI
mibe GmbH Arzneimittel0 个研究点开始时间: 2007年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •All of the following criteria have to be met for inclusion of a subject in the study:
- •- men or women aged between 18 and 65 years
- •- written informed consent of patient
- •- current diagnosis of persistent asthma according to generally acknowledged criteria
- •- daily regimen of inhaled corticosteroids in a low daily dose of 200 to 400 µg budesonide or equivalent for 4 weeks at least prior to study entry
- •- a forced expiratory volume in one second (FEV1) of less than 80% of the predicted value or personal best (if known)
- •- documented FEV1-reversibility of at least 12% (or at least 200 ml) from the pre-bronchodilator value
- •- capable of understanding the directions for device usage
- •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
- •Subjects are to be excluded from the study when one or more of the following conditions are met:
- •- daily regimen of inhaled long-acting beta-agonists (LABA) like formoterol or salmeterol for 4 weeks at least prior to study entry
- •- respiratory tract infection less than 6 weeks prior to study entry
- •- acute asthma attack, which led to hospitalisation less than 1 month prior to study entry
- •- smokers less than 6 weeks prior to study entry
- •- medical history of cystic fibrosis or bronchiectasis
- •- systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 95mm Hg and heart rate > 100 bpm
- •- known hypersensitivity to salmeterol or any of the ingredients of the study medication
- •- thyrotoxicosis, pheochromocytoma, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, aneurysm or other severe cardiovascular disorders
- •- patients with a history of diabetes mellitus and an unbalanced metabolic status
- •- other clinically significant conditions that might compromise patient safety, patient compliance, interfere with evaluations or preclude completion of the trial
- •- previous treatment within one month prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, as for example: xanthine derivatives, diuretics, laxatives, beta-adrenergic blockers
- •- abnormal 12-lead ECG at screening recorded after at least 5 min of rest in supine position
- •- prolonged QTc interval more than 460 ms for females and more than 440 ms for males
- •- female patients: pregnancy or lactation
- •- history of alcohol and/or drug and/or substance abuse
- •- unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period
- •- current participation in another clinical study or former participation in this study
研究者
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