EUCTR2004-001928-20-BE进行中（未招募）1 期
Open-label, multi-centre study to compare the effectiveness of QvarTM Autohaler therapy with conventional therapy (similar doses) in children with stable asthma
CB Pharma Belgium0 个研究点目标入组 300 人开始时间: 2005年8月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Written informed consent signed by child and both parents
- •- Children from 7 (inclusive) to 12 (inclusive) years old
- •- Diagnosed since at least 6 months with mild persistent to moderate persistent asthma (according the GINA Guidelines)
- •- Treated since at least 1 month with Seretide (fluticasonpropionate and salmeterol) 400 mcg max discus haler daily or Symbicort (budenoside and formoterolfumarate) 600 mcg max turbohaler daily
- •- >60% PEFR after withholding bèta-2-agonist therapy for at least 4 hours measured at visit 1
- •- Willing to comply with daily dairy recording and with visit schedule
- •- Otherwise healthy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Asthma treatment different from Seretide discus haler daily or Symbicort turbohaler daily
- •- Oral/ rectal/ intravenous corticoid treatment
- •- Hypersensitivity to one of the drugs used during study or for inhaled excipient.
- •- Continuous use of bèta-blockers
- •- Acute respiratory tract infection during the past 2 weeks
- •- Oral candidiasis which is clinically visible
研究者
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