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

Chiesi Farmaceutici0 个研究点目标入组 110 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 110

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•Written informed consent obtained from adult male or female (*18 and *65 years) patients with a 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:
•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 *2-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.

研究者

发起方

Chiesi Farmaceutici

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