EUCTR2009-014376-22-IT进行中（未招募）不适用
MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, TWO-ARM PARALLEL GROUPS STUDY DESIGN TO DEMONSTRATE THE EFFICACY AND TOLERABILITY OF A SINGLE DOSE OF BDP SUSPENSION FOR NEBULISATION 1600 mcg VS PLACEBO IN THE TREATMENT OF CHILDREN AGED 6 MONTHS TO 3 YEARS WITH A CLINICAL DIAGNOSIS OF MODERATE CROUP - ND
CHIESI0 个研究点开始时间: 2009年11月27日最近更新:
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 obtained by parents/legal representative prior to any study-related procedures; 2)Male or Female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress; 3)Children with a diagnosis of moderate croup (Westley score 3-8).
- •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)Symptoms or signs of any other cause of stridor; 2) Previous acute angioneurotic oedema; 3) Children with diagnosis of severe croup (Westley score > 8) 4) History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction; 5)Any other severe acute or chronic medical or psychiatriccondition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study; 6) Treatment with oral or parenteral corticosteroids within the previous 2 weeks; 7) Treatment with epinephrine for respiratory distress before enrollment; 8) Previous visit to an emergency room department due to croup during this episode of the disease; 9) Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments; 10) Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study; 11) Lack of a telephone at home.
研究者
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