An Evaluation of Efficacy and Safety of Corresponding Doses of Pulmicort Turbuhaler® and Pulmicort Respules® in Japanese Asthmatic Adult Patients (Open, Multicenter, Phase III Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Morning Peak Expiratory Flow (mPEF)
研究概览
简要总结
The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in Japanese adult asthmatic patients with age of 16 years or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures.
- •A minimum of 6 months documented history of asthma according to the JGL 2006 definition
- •Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.
排除标准
- •Current or previous tobacco smokers with a history of >= 10 pack-years
- •Use of β-blockers including eye drops
- •Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2
- •Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2
研究组 & 干预措施
1
Four weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
干预措施: Budesonide (Drug)
2
Pulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose)
干预措施: Pulmicort Turbuhaler (Drug)
结局指标
主要结局
Morning Peak Expiratory Flow (mPEF)
时间窗: 6 weeks
Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)
次要结局
- Evening Peak Expiratory Flow (ePEF)(6 weeks)
- Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)(6 weeks)
- Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)(6 weeks)
- Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)(6 weeks)
- Use of Rescue Medication (Daytime)(6 weeks)
- Use of Rescue Medication (Night-time)(6 weeks)
- Use of Rescue Medication (Total)(6 weeks)
- Night-time Awakenings Due to Asthma Symptoms(6 weeks)
- Forced Expiratory Volume in 1 Second (FEV 1.0)(6 weeks)
- Forced Vital Capacity (FVC)(6 weeks)
- Number of Participants With Adverse Events (AEs)(6 weeks)