ACTRN12623001339640尚未招募3 期
A 52 week, open-label, randomised, multi-centre, parallel group, phase III, controlled trial in children aged 4 to 11 years with moderate and severe asthma, evaluating the efficacy and safety of Budesonide-formoterol (Vannair®) as single maintenance and reliever therapy versus as prescribed maintenance asthma therapy and salbutamol (Ventolin®) as reliever therapy.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 376
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
- 4 Years 至 11 Years（—）
- 性别
- All
入选标准
- •1. Aged 4 to 11 years
- •2. Doctor or Nurse Practitioner (NP) diagnosis of asthma (self-report by parent/participant or healthcare provider-reported)
- •3. Use of maintenance ICS or ICS-LABA + SABA reliever therapy in the last 6 months (i.e. GINA step 2, 3 and 4)
- •4. Registered with a General Practitioner (GP)
- •5. Willing and able to switch from current treatment regimen
排除标准
- •1. Significant other comorbidity including, but not limited to, cystic fibrosis and bronchiectasis or arrythmia
- •2. Previous life-threatening asthma (ICU admission ever or intravenous (IV) treatment in last 2 years)
- •3. Already using ICS-LABA as a reliever
- •4. GINA step 5 (few children only, brittle asthma, and potentially difficult to manage in an RCT without regular face-to-face contact); use of biologics, high dose ICS-LABA, maintenance oral corticosteroids, or leukotriene receptor antagonists in the last 6 months
- •5. Systemic corticosteroids in last 6 weeks prior to Visit 1
- •6. Any known or suspected hypersensitivity (including rash, urticaria, angioedema, bronchospasm and anaphylactic reaction) to the active substances in the study (budesonide, formoterol, salbutamol)
- •7. Participation in another clinical trial of an investigational medicinal product in the 30 days prior to Visit 1
- •8. Ex-preterm infant (born <37 weeks)
研究者
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