Study of Montelukast In Children with Sickle Cell Disease (SMILES) - SMILES

Great Ormond Street Hospital for Children NHS Foundation Trust0 个研究点目标入组 200 人开始时间: 2020年10月14日最近更新: 2020年10月19日

适应症

试验速览

暂无简介。

•Aged between 3 and <8 years
•Informed consent with assent in accordance with institutional policies and European guidelines; ICF must be signed by patients/guardian
•HbSS or HbSß0 thalassaemia diagnosed by standard techniques (HPLC, IEF, MS or AlkE)
•History of Sleep-Disordered Breathing, (i.e. parent-reported any degree of snoring (CHSQ questionnaire) and/or any abnormality on overnight oximetry compared with published data in children of the same age (e.g. nadir SO2<93%; mean SO2<96%))
•In steady state i.e. haemoglobin not decreased by >10% in previous year, no painful crisis requiring opioids for at least 1 month and at least 1 month after any hospital admission
•Likely to comply with treatment for 3 months as determined by the local paediatrician or hematologist
•Able to speak and understand English
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•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

•Other developmental or psychiatric disorders including craniofacial abnormalities, neuromuscular disorder and other chronic conditions.
•Patient already on montelukast
•Patient has had side effects on or an adverse reaction to montelukast in the past
•Presence or history of another hemoglobinopathy or blood dyscrasia
•Concomitant treatment with any other leukotriene antagonist within a window period of enrolment
•Participation on other SCD/Montelukast trials

发起方