SMILES
Research type
Research Study
Full title
Study of Montelukast In Children with Sickle Cell Disease (SMILES)
IRAS ID
237674
Contact name
Fenella Kirkham
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Eudract number
2017-004539-36
Duration of Study in the UK
2 years, 8 months, 30 days
Research summary
Sickle cell disease (SCD) is a genetic blood condition causing long term health problems, including pain and brain problems, which affect quality-of-life. These may be made worse if patients have low night-time oxygen levels when the upper airways close repeatedly during the night (obstructive sleep apnoea) associated with snoring. This is associated with slow thinking speed, poor concentration, pain and kidney problems. Montelukast, widely used in the treatment of Asthma, has been shown to improve symptoms of obstructive sleep apnoea in patients without SCD. We think this treatment could be useful in patients with SCD too. Early intervention with Montelukast could help prevent deterioration in thinking speed and concentration.
The aim of this trial is to see whether young children with sickle cell disease randomised (randomise: the same as tossing a coin and not knowing whether it will come up heads or tails) to Montelukast treatment have better thinking skills compared with people randomised to placebo. This means that the child could be on Montelukast treatment or on placebo.
This trial, funded by Action Medical Research, will involve 200 SCD patients recruited from haematology clinics and ENT surgery waiting lists or their local sleep laboratory at Evelina Children's (Guy’s & St Thomas), University College London, North Middlesex, King's College and Whittington Hospitals. Patients are eligible if they are between 3 and <8 years old with SCD, give informed consent, have any Sleep-Disordered Breathing, e.g. snoring, and/or any abnormality on overnight oximetry. After consenting, the PI/Coordinator will organise a simple app-based questionnaire and baseline testing of thinking speed, with optional brain MRI and overnight oximetry, and randomisation to chewable Montelukast tablets or placebo for 3 months. Then the thinking speed tests, questionnaires and optional tests will be repeated.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0569
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion