EUCTR2006-005349-13-IT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 FOSTER PMDI VIA HFA-134A 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 - ND
CHIESI0 个研究点开始时间: 2007年4月12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
- •Inclusion into the 8-week run-in period consenting male and female adult age 18-65 years, limits included patients with moderate persistent asthma for more or equal to 6 months; FEV1 or PEFR more or equal to 80 of the predicted normal value; treated with stabilised fluticasone 1000 mcg salmeterol 100 mcg daily for more or equal to 4 weeks; patients with controlled asthma defined as no nocturnal symptoms or awakenings, no exacerbations, no limitations of activities, daytime symptoms and use of rescue medication less or equal to 2 days per week in the last 4 weeks. Cooperative attitude Inclusion into the treatment period 61472;asthma controlled in each of the last 4 weeks of run-in no nocturnal symptoms or awakenings; no exacerbations; no limitations of activities; daytime symptoms for less or equal to 2 days; use of rescue medication less or equal to 2 days; morning PEF more or equal to 80 of predicted every day .
- •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
- •Exclusion from the 8-week run-in period 61472;inability to carry out pulmonary function tests; 61472;diagnosis of COPD; 61472;current smokers or recent less or equal to 1 year ex-smokers with a smoking history of more or equal to 10 packs/years; 61472;history of near-fatal asthma; 61472;evidence of symptomatic infection of the airways in the previous 8 weeks; 61472;more or equal to 3 courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; 61472;treatment with anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks; 61472;his tory or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 61472;diabetes mellitus; 61472;percutaneous transluminal coronary angioplasty PTCA or coronary artery by-pass graft CABG during the previous six months; 61472;abnormal QTc interval value more to 450 msec in males or more to 470 msec in females in the ECG test or other haemodynamically relevant rhythm disturbances including atrial flutter or atrial fibrillation with ventricular response, bradicardia equal to 55 bpm , evidence of atrial-ventricular AV block on ECG of more than 1st degree; 61472;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; 61472;cancer or any chronic diseases with prognosis less to 2 years; 61472;pregnant or lactating females or females of childbearing potential not demonstrating adequate contraception; 61472;history of alcohol or drug abuse; 61472;regular treatment with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers; 61472;allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; 61472;Patients unlikely to comply with the protocol 61472; 61472;subjects treated with any investigational new drug within the last 12 weeks; 61472;subjects previously enrolled in this study.
研究者
相似试验
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 - FORTEEUCTR2006-005349-13-BGChiesi Farmaceutici SpA450
进行中（未招募）
不适用
Prospective, open-label, multicenter, non-randomized investigation on percutaneous patent foramen ovale (PFO) closure using the Occlutech PFO Occluder to prevent recurrence of stroke in patients with cryptogenic stroke and high risk PFOTHE PROOF STUDY – Occ2019_01 –Q24Other congenital malformations of heartDRKS00025198Occlutech International AB Landskronavägen 2574
招募中
不适用
Prospective, open-label, multicentre, non-randomized, non-interventional, exploratory, comparative, uncontrolled Post Market Clinical Follow-Up Study of the Modular Revision Support (MRS)-Titan® ComfortM16M87Coxarthrosis [arthrosis of hip]OsteonecrosisDRKS00014369PETER BREHM GmbH120
已完成
4 期
A Clinical Trial to Study the Safety and Efficacy of TLE-400mg Vs TLE-600mg in Indian Patients with HIV-1 Infection.CTRI/2017/11/010679Mylan Laboratories Limited265
已完成
不适用
PORTRAIT studyHypertgemiaD050171JPRN-jRCTs041200011Sumida Yoshio80