A Phase III, Randomized, Non-inferiority, Open-label, Comparative Study Between Foraseq® Inhalation Capsules, Eurofarma's Single Formoterol / Budesonide Inhalation Capsule and Single Alenia® Inhalation Capsule in Asthmatic Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 试验地点
- 5
- 主要终点
- Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
研究概览
简要总结
The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.
详细描述
The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.
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;
- •≥ 12 years old;
- •Have a diagnosis of mild to moderate 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-7 test <3,0;
- •Current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent);
- •Initial FEV1 of at least 50% of the normal value expected;
- •Serum cortisol evaluation within the normal limits
排除标准
- •Use of oral or parenteral corticosteroid within the last 3 months before the study;
- •Hospitalization needed due to asthma within the last 3 months before the study;
- •Active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months;
- •Presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma;
- •Recent participation (<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma;
- •Intolerance or allergy to any component of the drugs evaluated in the study;
- •Pregnant or lactating women;
- •Chronic use of routine β-blockers orally or intravenously, including ophthalmic solutions.
研究组 & 干预措施
Formoterol/Budesonide
formoterol and budesonide will be administered at the 12/400 µg dosage, twice a day for 12 weeks.
干预措施: Formoterol/Budesonide (Drug)
Foraseq
Foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
干预措施: Foraseq (Drug)
Alenia
Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
干预措施: Alenia (Drug)
结局指标
主要结局
Forced Expiratory Volume in 1 Second (FEV1) at the Final Visit (FV)
时间窗: 12 weeks
The primary efficacy analysis was performed by evaluating non-inferiority of Eurofarma's device compared to Alenia® in relation to FEV1 (in liters) in FV in the PP population
次要结局
- FEV1 (L) in VF in the ITT Population, to Assess the Difference Between the Three Groups(12 weeks)