NCT01197794已完成2 期
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,144
- 试验地点
- 1
- 主要终点
- Pre-bronchodilator FEV1 at the Clinic
研究概览
简要总结
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
- •6 months history of asthma according to ATS definition
- •Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
- •Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
- •A total ACQ5 score of 1.5 or more
排除标准
- •Respiratory infection significantly affecting the asthma
- •Any significant disease and disorder that may put the patient at risk or influence study results
- •Any clinically relevant abnormal findings
- •A smoking history of more than 10 pack years
- •Intake of oral, rectal or parenteral glucocorticosteroids
研究组 & 干预措施
AZD1981 10 mg
Experimental
AZD1981 10 mg
干预措施: AZD1981 (Drug)
AZD1981 40 mg
Experimental
AZD1981 40 mg
干预措施: AZD1981 (Drug)
AZD1981 100 mg
Experimental
AZD1981 100 mg
干预措施: AZD1981 (Drug)
AZD1981 400 mg
Experimental
AZD1981 400 mg
干预措施: AZD1981 (Drug)
AZD1981 80 mg
Experimental
AZD1981 80 mg
干预措施: AZD1981 (Drug)
AZD1981 200 mg
Experimental
AZD1981 200 mg
干预措施: AZD1981 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pre-bronchodilator FEV1 at the Clinic
时间窗: Twelve week treatment period
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
次要结局
- Morning and Evening PEF(Twelve week treatment period)
- Asthma Control Questionnaire 5-item (ACQ5)(Twelve week treatment period)
- Adverse Events(Twelve week treatment period)
- Number of Participants With at Least One Severe Asthma Exacerbation(Twelve week treatment period)
- Number of Participants With at Least One Treatment Failure(Twelve week treatment period)
- Number of Participants With Well-controlled Asthma (ACQ5<=0.75)(Twelve week treatment period)
- Asthma Quality of Life Questionnaire (AQLQ(S))(Twelve week treatment period)
- Asthma Symptom Score(Twelve week treatment period)
- Total Reliever Medication Use(Twelve week treatment period)
研究者
研究点 (1)
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