Treating severe paediatric asthma; a randomised controlled trial of mepolizumab and omalizumab (TREAT trial) - Treating severe paediatric asthma; the TREAT trial

Imperial College London0 个研究点目标入组 150 人开始时间: 2020年2月26日最近更新: 2020年8月10日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of asthma
•On high dose maintenance treatment (>/=800mcg per day budesonide/equivalent and long-acting beta agonist)
•At least 4 severe attacks (defined as the need for a short course of oral steroids, or hospitalisation) in the previous 12 months, OR if on maintenance oral steroids then at least 2 severe attacks in the last 12 months.
•Poor asthma control defined as a score of <20 on the Asthma Control Test (ACT) [children aged 12-16 years], or childhood Asthma Control Test (cACT) [children aged 6-11 years].
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1.As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study or has a risk of non-compliance with study procedures.
•2.The child has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
•3.Participant is female who is pregnant, lactating or within 6 weeks post-partum or breast feeding.
•4.The child has participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures.
•5.Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
•6.Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease
•7.Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)

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