ACTRN12622001217796招募中3 期
A 52-week, open-label, randomised, multi-centre, parallel group, phase III, controlled trial in patients age 5 to 11 years with mild, moderate and severe asthma, evaluating the efficacy and safety of Budesonide-formoterol (Symbicort Turbuhaler®) maintenance and/or reliever therapy compared with standard therapy: Budesonide (Pulmicort Turbuhaler®) maintenance or Budesonide-formoterol (Symbicort Turbuhaler®) maintenance, both with Terbutaline (Bricanyl Turbuhaler®) reliever.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 11 Years（—）
- 性别
- All
入选标准
- •1. Patients of any gender age five to 11 years (inclusive)
- •2. Doctor diagnosis of asthma (self-report by parent/participant or healthcare provider-reported)
- •3. Use of ICS or ICS-LABA maintenance plus SABA reliever therapy (corresponding to
- •GINA step 2, 3 or 4) in the 6 months prior to Visit 1
- •4. Registered with a General Practitioner
- •5. Satisfactory Turbuhaler technique
- •6. Inspiratory flow measurement of between 30 and 90 L/min
- •7. Provision of written informed consent (parent/guardian) and assent (participant)
- •8. Able and willing to switch from current treatment regimen
- •For randomisation at Visit 2, participants should fulfil the following criterion:
- •9. Satisfactory Turbuhaler technique
- •10. Inspiratory flow measurement of between 30 and 90 L/min
排除标准
- •1. Already using ICS-formoterol or ICS-Salbutamol as a reliever
- •2. Any use of high dose ICS-LABA (New Zealand Child Asthma Guidelines Step 5), biologics, maintenance oral corticosteroids (i.e. GINA Step 5), or leukotriene receptor antagonists in the last 6 months
- •3. Any use of systemic corticosteroids in the 6 weeks prior to Visit 1
- •4. Use of a beta-blocker in the 6 months prior to Visit 1
- •5. Any medical condition which, at the Investigator’s discretion, may present a safety risk or impact the feasibility of the study or the study results (including, but not limited to, other significant respiratory comorbidities, such as cystic fibrosis and bronchiectasis)
- •6. Any known or suspected hypersensitivity (including rash, urticaria, angioedema, bronchospasm and anaphylactic reaction) to the active substances prescribed in the study (budesonide, formoterol, terbutaline), lactose or milk protein (excipient)
- •7. Any intravenous therapy for the treatment of asthma, in the last year.
- •8. Previous Intensive Care Unit admission for asthma, or ventilation for asthma, ever
- •9. Participation in another clinical trial of an investigational medicinal product in the 30 days prior to Visit 1
- •For randomisation at Visit 2, participants are excluded from the study if the following criteria apply:
- •10. Any severe exacerbation, or 2 moderate exacerbations (per protocol defined criteria) and/or a change in asthma treatment other than run-in study medication from Visit 1 until Visit 2
研究者
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