SMILES: Study of Montelukast in Sickle Cell Disease
Status:
Not yet recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
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). This is associated with increased pain, poorer
concentration and increased kidney problems. Montelukast, widely used in the treatment of
Asthma, has been shown to improve symptoms of obstructive sleep apnoea in patients without
sickle cell anaemia. Investigators think this treatment could be useful in patients with
sickle cell disease too. Early intervention with Montelukast could help prevent deterioration
in concentration and thinking skills.
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 (tablet with no active medical ingredients - i.e. "sugar pill"). This means that
the child could be on Montelukast treatment or he/she might be on placebo tablets.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators:
Guy's and St Thomas' NHS Foundation Trust King's College Hospital NHS Trust North Middlesex University Hospital The Whittington Hospital NHS Trust University College London Hospitals