EUCTR2008-003740-11-ES进行中（未招募）不适用
Estudio Fase IV, multinacional, multicéntrico, doble ciego, doble simulación, randomizado, de grupos paralelos, controlado, sobre la combinación de dosis fijas de Dipropionato de Beclometasona 100 µg más Fumarato de Formoterol 6 µg pMDI con propelente HFA-134A (CHF1535, FOSTER®) versus Fluticasona 250 µg más Salmeterol 50 µg IPS (SERETIDE® DISKUS®) como tratamiento de mantenimiento de pacientes asmáticos controlados.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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 452
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
- •1.Written informed consent obtained
- •2.Adult male and female (equal to and between 18 and 65 years)
- •3.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) greater than or equal to 80% predicted or personal best (if known)
- •4.Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for greater than or equal to 4 weeks
- •5.A co-operative attitude and ability to correctly use the device and to complete the diary cards
- •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
- •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 Beta2-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 investigators opinion;
- •9.Patients with a serum potassium value below or equal to 3.5 mEq/L
- •10.Patients with QTc interval (Bazetts 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
相似试验
进行中（未招募）
不适用
Estudio de fase IV, multicéntrico, abierto, para investigar la seguridad y eficacia a largo plazo de la administración de Dynepo por vía subcutánea en pacientes adultos con anemia asociada a nefropatía crónica.An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients with Anaemia Associated with Chronic Kidney Disease. - Seguridad a largo plazo de la administración de DynepoAnemia asociada a nefropatía crónicaAnaemia in Chronic Kidney Disease (CKD)EUCTR2007-000054-31-ESShire416
进行中（未招募）
不适用
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 studyMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaAsthmaEUCTR2008-003740-11-DEChiesi Farmaceutici S.p.A.452
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 PATIENTSlung inflammation10024967asthmaNL-OMON33799Chiesi Farmaceutici110
进行中（未招募）
不适用
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 studyMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaAsthmaEUCTR2008-003740-11-NLChiesi Farmaceutici S.p.A.452
进行中（未招募）
1 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. - FACTO studyAsthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2008-003740-11-FRChiesi Farmaceutici S.p.A.452