NCT00989833已完成2 期
A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbutaline "As-needed", in Patients With Mild Intermittent Asthma
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
- 66
- 试验地点
- 1
- 主要终点
- Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
研究概览
简要总结
- The primary objective of this study is:
- To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
- The secondary objectives of this study are:
- To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
- To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of exercise induced asthma
- •Maximum 4 asthmatic episodes per week requiring use of reliever medication
排除标准
- •No previous treatment with inhaled oral corticosteroids during the last month before randomisation
- •Suspected poor capability to follow instructions, ie to exercise 3-4 times a week
研究组 & 干预措施
A
Active Comparator
budesonide 400yg + terbutaline 0.4 mg as-needed
干预措施: budesonide (Drug)
A
Active Comparator
budesonide 400yg + terbutaline 0.4 mg as-needed
干预措施: terbutaline (Drug)
B
Active Comparator
placebo + terbutaline 0.4 mg as-needed
干预措施: terbutaline (Drug)
C
Active Comparator
placebo + budesonide/formoterol 160/4.5 yg as-needed
干预措施: budesonide/formoterol (Drug)
结局指标
主要结局
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
时间窗: Baseline and Visit 6
FEV1
次要结局
- Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks(Baseline and 3 weeks)
- Bronchial Responsiveness to Mannitol(Baseline and 6 weeks)
- Concentration of Exhaled Nitric Oxide(6 weeks)
- Use of as Needed Medication(6 weeks)
- Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)(Baseline e and 6 weeks)
- Diary Recording of Asthma Symptoms(6 weeks)
- Number of Participants With an Adverse Event During the Study(6 weeks)
研究者
研究点 (1)
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