Status:
UNKNOWN
SMILES: Study of Montelukast in Sickle Cell Disease
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
University College London Hospitals
Conditions:
Anemia, Sickle Cell
Sleep-Disordered Breathing
Eligibility:
All Genders
3-8 years
Phase:
PHASE2
PHASE3
Brief 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 ni...
Detailed Description
This trial, funded by Action Medical Research, will involve 200 SCD patients recruited from haematology clinics and ENT (ear, nose and throat) surgery waiting lists or their local sleep laboratory at ...
Eligibility Criteria
Inclusion
- Aged between 3 and \<8 years
- Informed consent with assent in accordance with institutional policies and European guidelines; ICF (informed consent form) must be signed by patients/guardian
- HbSS 9homozygous SS disease) or HbSβ0 thalassaemia diagnosed by standard techniques (HPLC, IEF (Isoelectric focusing), MS (Mass spectrometry) 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 (oxygen saturation) \<93%; mean SO2\<96%))
- Able to speak and understand English
Exclusion
- Other neurodevelopmental disorders
- Patient already on Montelukast
- Patient has had side effects on or an adverse reaction to Montelukast in the past
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04351698
Start Date
October 16 2023
End Date
September 30 2024
Last Update
November 1 2023
Active Locations (1)
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1
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom, WC1N 1EH