EUCTR2010-023981-27-DE进行中（未招募）不适用
An Open-Label Randomized Pilot Trial to Evaluate Tolerability, Safety and Applicability of AKITA Inhaled Budesonide Suspension in Children aged 3-11 years with Mild to Moderate Asthma - SCIPE-001 – Safe Corticosteroid Inhalation in Pediatrics
Activaero GmbH0 个研究点开始时间: 2011年1月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1) Written informed consent performed by parents or legal representatives of the child prior to the performance of any study-related procedures. Verbal assent of the child if in the Investigator’s opinion the child is capable of giving the assent.
- •2) Age = 3 and = 11 year of age
- •3) Diagnosis of mild-to-moderate asthma (ATS definition, either allergic or non-allergic) for = 6 months and currently stable Asthma treated for at least 3 months with inhaled (ICS) corticosteroids (MDI/DPI). Current ICS treatment will be suspended during the treatment phase of the trial. Treatment with additional leukotriene antagonists (e.g. Montelukast) is allowed and remains unchanged throughout the study.
- •4) FEV1 = 50% predicted at the Screening or Baseline Visit (children aged 6 years or older and able to perform spirometry)
- •5) Documented increase of at least 12% in absolute FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 6 months prior to Screening (children aged 6 years or older and able to perform spirometry).
- •6) A negative urine pregnancy test must be available for any girl of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)
- •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
- •1) History of allergy or adverse experience with Budesonide
- •2) Upper respiratory tract infection within 4 weeks of Screening
- •3) Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
- •4) Hospitalization for asthma within 3 months of Screening
- •5) Use of inhaled LABA, theophylline, anti-IgE, or oral corticosteroids within 3 months of Screening.
- •6) Treatment with other investigational asthma treatment within 30 days prior to Screening.
- •7) Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), chronic bronchitis and emphysema
- •8) History of medication noncompliance
- •9) History of significant medical illness or condition that in the Investigator’s opinion places the subject at undue risk by participating in the study
- •10) Past episode of anaphylaxis with severe respiratory symptoms
- •11) Taking oral or i.v. corticosteriods for any disease indication
研究者
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