Anemia, Sickle CellPhase 2/3SMILESNCT04351698
SMILES: Study of Montelukast in Sickle Cell Disease
A Phase 2/3 study testing Montelukast in people with Anemia, Sickle Cell and Sleep-Disordered Breathing, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia, Sickle Cell, Sleep-Disordered Breathing
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2023to 30 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Other neurodevelopmental disorders
- Patient already on Montelukast
- Patient has had side effects on or an adverse reaction to Montelukast in the past
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital NHS Foundation Trust
London, WC1N 1EH
Sati OSHNF Sahota, s.sahota@ucl.ac.uk
Fenella Kirkham, MD, FRCP, FRCPCH
About this study
Official title: Study of Montelukast In ChiLdrEn With Sickle Cell Disease (SMILES)
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.
Read the 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 Evelina Children's hospital (Guy's \& St Thomas), University College London hospital, North Middlesex hospital and Whittington Hospitals. Patients are eligible if they are between 3 and <8 years old w 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 brain speed, with an optional brain scan, and randomisation to chewable Montelukast tablets or Placebo for 3 months after which the brain speed tests, questionnaires and MRI will be repeated.
Purpose and design:
This is designed as a phase 2/3 trial of Montelukast therapy to investigate whether this drug improves processing speed, which appears to underpin the difference in full scale IQ (intelligence quotient) United Kingdom.
between children with sickle cell disease and their siblings.
Recruitment:
Patients will be recruited from the paediatric and adult sickle clinics at the involved hospitals. These clinics are attended by over 2000 patients with sickle cell disease.
This is a paediatric trial in a group of children who mainly belong to an ethnic minority as it is this age group who are vulnerable to sleep-disordered breathing (90% of children with sickle cell disease in our previous study snored). The investigators have successfully run 4 previous randomised controlled trials and 2 longitudinal studies in this group of children. The proposal has been developed by a multidisciplinary team of researchers/scientists, many of whom have lengthy clinical experience in this area. This team includes two patient representatives. Processing speed has been measured until recently using the Coding and Symbol search Wechsler subtests but investigators found that there was a practice effect in both arms of our pilot trial of continuous positive airways pressure, which was not seen for Cancellation, another test of processing speed and attention. The NIH toolbox processing speed is a new iPad test which has extensive normal data down to the age of 3 years, but a team member who has used it has found a practice effect. Investigators are therefore including 2 primary endpoints: Cancellation and the NIH toolbox processing speed It is possible that investigators will not recruit 200 patients across the 4 London sites so:
- Investigators have ensured that they will be adequately powered to detect an effect of Montelukast on adenoid: nasopharynx ratio on MRI if they recruit at least 3 willing to undergo MRI in each arm; this will allow exploration of the secondary brain MRI endpoints in addition to the primary endpoints.
- Investigators will extend to additional UK sites
- Investigators will apply for additional funds to extend the study outside the UK, e.g. by applying for $500,000 from the National Heart Lung and Blood Institutes (USA) to run the study in Cincinnati and New York.
- Conditions
- Anemia, Sickle Cell, Sleep-Disordered Breathing
- Being tested
- Montelukast, Oral Placebo
- Medical subject headings
- Anemia, Sickle Cell, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called singulair
Montelukast is used to treat and prevent asthma. It will decrease the symptoms and the number of acute asthma attacks. However this medicine should not be used to relieve an asthma attack that has already started.
Oral PlaceboOther
Inert chewable tablet with no therapeutic value
| Study group | Role | What they receive |
|---|---|---|
| Investigation | Active comparator | Montelukast Receives: Drug: Montelukast |
| Match Placebo | Placebo comparator | Matched Placebo Receives: Other: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in processing speed scores from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
NIH toolbox processing speed
Measured: 12 weeks
Change in processing speed scores from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Cancellation (Wechsler scales and paper-and-pencil)
Measured: 12 weeks
Secondary outcomes (6)
Change in executive function (from NIH Toolbox® Cognition Battery) from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Dimensional Change Card Sort Test: There are 40 trials, and scoring was based on a combination of accuracy and reaction time.
Flanker Inhibitory Control and Attention Test: There are 40 trials. For children aged 3-7.99 years scores of ≥ 90% using preliminary fish stimuli were followed that an additional 20 trials using arrows. Scoring was based on a combination of accuracy and reaction time.
List Sorting Working Memory Test: The number of items in series increases from 2 to a maximum of 8. The test was discontinued when 2 trials at the same length were failed. Responses were entered by the examiner on a wireless keyboard. Children under 7 years did not complete this test. Scoring was based on the total number of items correctly recalled across all trials.
Each measure will be analysed separately and as a combined composite. Higher scores indicate better executive function (mean = 100, standard deviation = 15, range = 50 - 150).
Measured: 12 weeks
Change in executive function (parent reported questionnaire) from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Behavioral Rating Inventory of Executive Function (BRIEF-2) is an 63-item questionnaire that assesses EF behaviours in the school and home environments. The Global Executive Composite, Behavioural Regulation, and Emotion Regulation indices will be used in analyses. Higher T-scores (> 65) indicate more clinical concern (range = 0 - 100).
Measured: 12 weeks
Change in sleep and respiratory symptoms from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Children's Sleep Habit questionnaire (CSHQ): a 45-item parent-rated questionnaire that assesses the frequency of behaviors associated with common paediatric sleep difficulties (range = 0 - 135).
Pediatric Sleep Questionnaire: a 22-item parent-rated questionnaire that asks about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behaviour (range = 0 - 22).
Total sleep time/total scores will be used in analyses. Higher scores are of greater clinical concern.
Measured: 12 weeks
Change in pain symptoms from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Pain and hurt and pain management and control scales from the PedsQL - Sickle Cell Module: The PedsQL is a 43-item questionnaire with 9 dimensions that assesses health-related quality of life in individuals with SCD (pain and hurt range = 0 - 36, pain management and control range = 0 - 8).
Total scores will be used in analyses. Lower scores are of greater concern.
Measured: 12 weeks
Number of Participants With Treatment-Related Adverse Events from Montelukast
All AEs (adverse events), hospital attendances, days of illness, and days lost from pre-school/school to be recorded on CRFs (case report forms) by coordinator and encrypted and stored separately
Measured: 12 weeks
Change in Brain MRI from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Adenoidal size, volumetrics, white-matter integrity, structural and functional connectivity, perfusion) and nocturnal oximetry will be measured.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start16 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, North Middlesex University Hospital, King's College Hospital NHS Trust, The Whittington Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Fenella Kirkham, MA MB Bchir, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351698
- Sponsor's protocol ID
- Protocol Number: 16NC06
- Acronym
- SMILES
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hood AM, Stotesbury H, Kolbel M, DeHaan M, Downes M, Kawadler JM, Sahota S, Dimitriou D, Inusa B, Wilkey O, Pelidis M, Trompeter S, Leigh A, Younis J, Drasar E, Chakravorty S, Rees DC, Height S, Lawson S, Gavlak J, Gupta A, Ridout D, Clark CA, Kirkham FJ. Study of montelukast in children with sickle cell disease (SMILES): a study protocol for a randomised controlled trial. Trials. 2021 Oct 10;22(1):690. doi: 10.1186/s13063-021-05626-6.
PubMed 34629091
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Montelukast In ChiLdrEn With Sickle Cell Disease (SMILES)
- ClinicalTrials.gov ID
- NCT04351698
- Acronym / sponsor ID
- SMILES / Protocol Number: 16NC06
- Conditions
- Anemia, Sickle Cell, Sleep-Disordered Breathing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, North Middlesex University Hospital, King's College Hospital NHS Trust, The Whittington Hospital NHS Trust
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Evelina Children's hospital (Guy's \& St Thomas), University College London hospital, North Middlesex hospital and Whittington Hospitals. Patients are eligible if they are between 3 and <8 years old w 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 brain speed, with an optional brain scan, and randomisation to chewable Montelukast tablets or Placebo for 3 months after which the brain speed tests, questionnaires and MRI will be repeated.
Purpose and design:
This is designed as a phase 2/3 trial of Montelukast therapy to investigate whether this drug improves processing speed, which appears to underpin the difference in full scale IQ (intelligence quotient) United Kingdom.
between children with sickle cell disease and their siblings.
Recruitment:
Patients will be recruited from the paediatric and adult sickle clinics at the involved hospitals. These clinics are attended by over 2000 patients with sickle cell disease.
This is a paediatric trial in a group of children who mainly belong to an ethnic minority as it is this age group who are vulnerable to sleep-disordered breathing (90% of children with sickle cell disease in our previous study snored). The investigators have successfully run 4 previous randomised controlled trials and 2 longitudinal studies in this group of children. The proposal has been developed by a multidisciplinary team of researchers/scientists, many of whom have lengthy clinical experience in this area. This team includes two patient representatives. Processing speed has been measured until recently using the Coding and Symbol search Wechsler subtests but investigators found that there was a practice effect in both arms of our pilot trial of continuous positive airways pressure, which was not seen for Cancellation, another test of processing speed and attention. The NIH toolbox processing speed is a new iPad test which has extensive normal data down to the age of 3 years, but a team member who has used it has found a practice effect. Investigators are therefore including 2 primary endpoints: Cancellation and the NIH toolbox processing speed It is possible that investigators will not recruit 200 patients across the 4 London sites so:
- Investigators have ensured that they will be adequately powered to detect an effect of Montelukast on adenoid: nasopharynx ratio on MRI if they recruit at least 3 willing to undergo MRI in each arm; this will allow exploration of the secondary brain MRI endpoints in addition to the primary endpoints.
- Investigators will extend to additional UK sites
- Investigators will apply for additional funds to extend the study outside the UK, e.g. by applying for $500,000 from the National Heart Lung and Blood Institutes (USA) to run the study in Cincinnati and New York.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigation | Active comparator | Drug: MontelukastMontelukast |
| Match Placebo | Placebo comparator | Other: Oral PlaceboMatched Placebo |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Other neurodevelopmental disorders
- Patient already on Montelukast
- Patient has had side effects on or an adverse reaction to Montelukast in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastAlso: singulairMontelukast is used to treat and prevent asthma. It will decrease the symptoms and the number of acute asthma attacks. However this medicine should not be used to relieve an asthma attack that has already started. | Drug | Investigation |
| Oral PlaceboInert chewable tablet with no therapeutic value | Other | Match Placebo |
Primary outcome
Change in processing speed scores from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
NIH toolbox processing speed
Change in processing speed scores from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Cancellation (Wechsler scales and paper-and-pencil)
6 secondary outcomes
Change in executive function (from NIH Toolbox® Cognition Battery) from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Change in executive function (parent reported questionnaire) from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Change in sleep and respiratory symptoms from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Change in pain symptoms from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Number of Participants With Treatment-Related Adverse Events from Montelukast
Time frame: 12 weeks
Change in Brain MRI from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm.
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 34629091Hood AM, Stotesbury H, Kolbel M, DeHaan M, Downes M, Kawadler JM, Sahota S, Dimitriou D, Inusa B, Wilkey O, Pelidis M, Trompeter S, Leigh A, Younis J, Drasar E, Chakravorty S, Rees DC, Height S, Lawson S, Gavlak J, Gupta A, Ridout D, Clark CA, Kirkham FJ. Study of montelukast in children with sickle cell disease (SMILES): a study protocol for a randomised controlled trial. Trials. 2021 Oct 10;22(1):690. doi: 10.1186/s13063-021-05626-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fenella Kirkham, MA MB Bchir principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Montelukast in people with Anemia, Sickle Cell and Sleep-Disordered Breathing, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenella Kirkham, MA MB Bchir (+44 207 9052191, fenella.kirkham@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in processing speed scores from baseline to 12 weeks for participants with sickle cell disease randomised to the control arm or the treatment arm. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.