A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 654
- 试验地点
- 52
- 主要终点
- Time to First Severe Asthma Exacerbation
研究概览
简要总结
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).
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
- None
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
- •Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
- •Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit
- •Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
- •A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
- •Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
排除标准
- •Previous treatment with Symbicort Single Inhaler;
- •Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
- •Known or suspected hypersensitivity to study therapy or excipients.
- •A history of smoking ≥ 10 pack years.
- •Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
结局指标
主要结局
Time to First Severe Asthma Exacerbation
时间窗: Baseline up to 6 months
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.
次要结局
- Total Number of Severe Exacerbations(Baseline up to 6 months)
- Mean Use of as Needed Medication(Baseline up to 6 months)
- Use of Inhaled Steroids(Baseline up to 6 months)
- Change in the Asthma Control Questionnaire(ACQ) Score(Daily 14 days prior to each of visit 2-4)
- Peak Expiratory Flow (PEF)(6 months (end of the study))