A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,850
- 试验地点
- 1
- 主要终点
- 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
研究概览
简要总结
The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.
详细描述
A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 130 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Symbicort "as needed"+placebo Pulmicort bid
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
干预措施: budesonide/formoterol 'as needed' + budesonide placebo bid (Drug)
terbutaline "as needed"+placebo Pulmicort bid
terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid
干预措施: terbutaline 'as needed' + placebo budesonide bid (Drug)
Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
干预措施: budesonide bid + terbutaline 'as needed' (Drug)
结局指标
主要结局
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)
时间窗: Weekly, up to 52 weeks
A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score \>1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
次要结局
- Average Change From Baseline in Evening PEF(up to 52 weeks)
- Number of Participants Experiencing at Least One Severe Asthma Exacerbation(Day 1 up to 52 weeks)
- Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation(Day 1 up to 52 weeks)
- Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)(Study weeks 0,4,16,28,40,52)
- Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma(up to 52 weeks)
- Average Change From Baseline in Morning Peak Expiratory Flow (PEF)(up to 52 weeks)
- Change From Baseline in Percentage of 'As Needed' Free Days(up to 52 weeks)
- Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.(up to 52 weeks)
- Average Change From Baseline in Asthma Symptom Score(up to 52 weeks)
- Change From Baseline in Percentage of Symptom-free Days(up to 52 weeks)
- Change From Baseline in Percentage of Asthma Control Days(up to 52 weeks)
- Number of Patients With Study Specific Asthma Related Discontinuation(up to 52 weeks)
- Poorly Controlled Asthma Weeks(Weekly for up to 52 weeks)
- Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma(Day 1 up to 52 weeks)
- Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)(Study weeks 0,4,16,28,40,52)
- Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))(Study weeks 0,16,28,40,52)
- Percentage of Controller Use Days(up to 52 weeks)
- Annual Severe Asthma Exacerbation Rate(up to 52 weeks)
- Annual Moderate or Severe Asthma Exacerbation Rate(up to 52 weeks)