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
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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