Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 主要终点
- Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
研究概览
简要总结
To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.
详细描述
the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day.
The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of uncontrolled asthma
- •Age ranged from 18 to 77 years
- •Nonsmokers
排除标准
- •Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
- •Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
- •Diabetes mellitus
- •Pregnancy
- •Neuropsychiatric diseases
- •Pulmonary malformations, tuberculosis, Cystic fibrosis
- •Immunosuppressive treatment
- •Hospitalization for asthma or respiratory infection in last 30 days
- •Severe systemic disease
研究组 & 干预措施
Fixed Combination of Budesonide and formoterol
Group 1 (experimental): Fixed Combination of Budesonide and formoterol
干预措施: Fixed combination of budesonide and formoterol (Drug)
Budesonide
Group 2 (comparator): Budesonide
干预措施: Budesonide (Drug)
结局指标
主要结局
Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
时间窗: 12 weeks
the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
次要结局
未报告次要终点