NCT01202084已完成3 期
A Phase III, Randomized, Open-label, Non-inferiority Study Comparative of Formoterol/Fluticasone Eurofarma 12/250 µg, Foraseq® 12/400 µg and Fluticasone 500 µg in Asthma Patients
Eurofarma Laboratorios S.A.1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in 1 second (FEV1) at final visit.
研究概览
简要总结
The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the ICF
- •Age ≥ 12 years
- •Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
- •Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
- •Initial FEV1 of at least 40% of the predicted normal value
- •Serum cortisol assessment within normal values.
排除标准
- •Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
- •Requirement of admission due to asthma within the 3 months prior to study beginning
- •Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
- •Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
- •Recent (< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
- •Intolerance or allergy to any of the components of the drugs assessed in the study
- •Pregnancy or lactation
- •Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions
研究组 & 干预措施
Formoterol/Fluticasone Eurofarma
Experimental
formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks
干预措施: Formoterol/Fluticasone (Drug)
Foraseq®
Active Comparator
formoterol + budedonide (12/400 mcg) twice a day per 12 weeks
干预措施: Foraseq® (Drug)
Fluticasone
Active Comparator
fluticasone (500 mcg) twice a day per 12 weeks
干预措施: Fluticasone (Drug)
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) at final visit.
时间窗: 12 weeks
次要结局
- Peak expiratory flow (PEF)(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Non- Inferiority Comparative Study Between Seretide® and Salmeterol/Fluticasone Eurofarma in Patients with AsthmaAsthmaNCT01202097Eurofarma Laboratorios S.A.334
终止
不适用
Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166Type 2 Diabetes MellitusType 1 Diabetes MellitusNCT01201928Mannkind Corporation3
已完成
3 期
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria PatientsFalciparum MalariaNCT00403260Medicines for Malaria Venture1,271
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and DyslipidemiaEssential Hypertension, DyslipidemiaNCT03338426Boryung Pharmaceutical Co., Ltd133
已完成
3 期
Combination of Fimasartan/Amlodipine/Rosuvastatin in Patients With Essential Hypertension and DyslipidemiaEssential HypertensionDyslipidemiaNCT03156842Boryung Pharmaceutical Co., Ltd138