A Clinical Study Comparing Symbicort 'as Needed' 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
- 4,215
- 试验地点
- 1
- 主要终点
- Annual Severe Asthma Exacerbation Rate - Superiority Analysis
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 Pulmicort (budesonide) Turbuhaler twice daily plus terbutaline Turbuhaler 'as needed'
详细描述
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group 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 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
- •Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required
- •Male or Female, ≥12 years of age
- •Documented diagnosis of asthma for at least 6 months prior to Visit 1
- •Patients who are in need of GINA step 2 treatment
- •Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
- •Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN
- •Patients should have reversible airway obstruction
- •To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3 separate days during the last week of the run in period
排除标准
- •Patient has a history of life-threatening asthma including intubation and intensive care unit admission
- •Patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
- •Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
- •Current or previous smoker with a smoking history of ≥ 10 pack years
- •Pregnancy, breast-feeding or planned pregnancy during the study
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)
Pulmicort bid + terbutaline "as needed"
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
干预措施: budesonode bid + terbutaline 'as needed' (Drug)
结局指标
主要结局
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
时间窗: up to 52 weeks
Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
时间窗: up to 52 weeks
Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation
次要结局
- Average Change From Baseline in Pre-bronchodilator FEV1(Study weeks 0,17, 34, 52)
- Average Change From Baseline in 'as Needed' Use(Week 0 up to 52 weeks)
- Number of Participants Experiencing at Least One Severe Asthma Exacerbation(Day 1 up to 52 weeks)
- Number of Participants With Study Specific Asthma Related Discontinuation(Day 1 up to 52 weeks)
- Change From Baseline in Percent of 'as Needed' Free Days(Week 0 up to 52 weeks)
- Percentage of Controller Use Days(Week 0 up to 52 weeks)
- Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score(Study weeks 0, 17, 34, 52)
- Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score(Study weeks 0,17, 34, 52)