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临床试验/EUCTR2009-015626-11-GB
EUCTR2009-015626-11-GB进行中(未招募)1 期

Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype. - Wheeze And Intermittent Treatment; WAIT

Queen Mary University London0 个研究点目标入组 1,346 人开始时间: 2010年3月17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)
入组人数
1,346

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

入选标准

  • age = 10 months and = 5 years on the day of the first dose of IMP.
  • two or more attacks of parent-reported wheeze,
  • at least one attack with wheeze validated by a clinician
  • the most recent attack within the last 3 months.
  • contactable by telephone and able to attend one face-to-face review for issue of IMP
  • parent or guardian able to give written informed consent for their child participate in the study.
  • 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

  • •any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis
  • any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty
  • history of neonatal chronic lung disease
  • current continuous oral montelukast therapy
  • in a trial using an IMP within the previous 3 months prior to recruitment.

研究者

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