A Phase III, Randomized, Open-Label, Non-Inferiority Comparative Study Between Foraseq Inhalation Capsules 12/200 Μg and Formoterol/ Budesonide Inhalation Capsules 12/200 Μg Eurofarma in Patients with Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
研究概览
简要总结
This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma.
详细描述
This study primary objective is to compare the impact of two products containing budesonide and formoterol as individual capsules with inhalation powder for the pulmonary function of subjects with persistent asthma. This is a non-inferiority study, which hypothesis is that there is no difference on the pulmonary function measure between the groups studied at its end. Therefore, the study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
This study secondary objective is to compare the impact on the clinical control of two products containing budesonide and formoterol as individual capsules with inhalation powder in subjects with persistent asthma.
The secondary endpoints considered for this study are:
- Score of asthma control questionnaire (ACQ-7) 34 at the end of the study ;
- Peak of expiratory flow (PEF) throughout the study;
- Symptoms score at the end of the study;
- FEV1 throughout the study;
- Treatment safety, including serum cortisol dosage;
- Frequency of observed adverse events.
Some eligibility criteria:
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 ICF (see Attachment A);
- •Age ≥12 years old
- •Diagnosis of mild to moderate persistent asthma, as per the ARIA classification, 35 with symptoms for at least 6 months, clinically stable for at least 1 month with ACQ-7 test34 (see Attachment D) < 3.0;
- •Current use of inhaled corticosteroids (equivalent to beclometasone dipropionate 1000µg) associated or not to long-acting β2-adrenergics and relief medication (salbutamol or equivalent);
- •Initial FEV1 of at least 50% of the normal value estimated.
- •Serum cortisol evaluation within the normal values
排除标准
- •Use of oral or parenteral corticosteroids within the last 3 months;
- •Need of hospitalization due to asthma within the last 3 months;
- •Active tabagism, defined as the use of cigarettes, pipe, cigar or any other type in any amount within the last 3 months;
- •Severe co-morbidity, such as cardiovascular, renal, liver, neurologic, neoplastic, blood, infectious, dermatologic, neurologic, psychiatric or chronic respiratory diseases, other than asthma;
- •Recent participation (<6 months) or planned participation, during this study, on other clinical trials involving drugs of any nature or under studies of any type of intervention for the asthma treatment;
- •Intolerance or allergy to any of the compounds of the drugs evaluated on the study;
- •Pregnancy or lactation;
- •Chronic use of routine oral or intravenous β-blocker drugs, even ophthalmic solutions.
研究组 & 干预措施
Formoterol/Budesonide
干预措施: Formoterol/Budesonide (Drug)
Foraseq
干预措施: Foraseq (Drug)
结局指标
主要结局
The study primary endpoint will be the forced expiratory volume in 1 second (FEV1) at the final visit (FV) at each study arm.
时间窗: 4 months
次要结局
- Only one Score of asthma control questionnaire (ACQ-7) 34 at the end of the study.(4 months)