CTRI/2017/03/008277尚未招募3 期
Comparative study of the efficacy and safety of Formoterol, dry powder capsules for inhalation, 12 µg and Foradil, inhalation powder, capsules, 12 µg in patients with partially controlled bronchial asthma“
Rus Biopharm LLC1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2017年4月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change in FEV1
研究概览
简要总结
This study is designed as anopen-label, multicentre, randomized, comparative trial.
The total duration of the Study for each patient willnot exceed 109 days, of which the duration of screening will not exceed 14days, the duration of the treatment period 84 days, and the duration of thefollow-up period 11 days.
The study will include the following periods:
Study Visits
Visit 0 (screening, Day -14 ... -1);
Visit 1 (randomization, Day 1);
Visit 2 (interim visit, Day 14 ± 2);
Visit 3 (interim visit, Day 56 ± 2);
Visit 4 (completion of therapy, Day 86 ± 2);
Visit 5 (telephone call, Day 93 ± 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients 18 to 70 years of age inclusive.
- •2.Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit.
- •3.Need for combination bronchodilator therapy with long-acting beta-agonists in combination with inhaled glucocorticoids (IGC).
- •4.Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy.
排除标准
- •1.Patients for whom starting maintenance therapy for asthma has to be selected. 2.Contraindications for treatment with inhaled glucocorticoids, hypersensitivity to formoterol, salbutamol, or to any other ingredient included in the formulation of the investigational medicinal product, reference product, or salbutamol. 3.Galactose intolerance, lactase deficiency, or glucose.
- •galactose malabsorption. 4.Body mass index (BMI) > 35 kg/m
- •5.A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2015 version of the GOLD guidelines.
结局指标
主要结局
Change in FEV1
时间窗: By the 2nd hour post inhalation during Visits 1 and 4.
次要结局
- Change in FEV1(by the 2nd hour post inhalation during Visits 2, 3, and 4.)
- Changes in absolute PEF(by Visits 2, 3, and 4.)
- Total ACQ-5 (asthma control questionnaire) score changes(by Visits 2, 3, and 4.)
- SF-36 (quality of life questionnaire) score changes(by Visits 2 and 4.)
- Proportion of patients achieving asthma control (total ACQ-5 score 0.75)(by Visit 4.)
研究者
研究点 (1)
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