NCT07402707 Dosing of Steroids for Acute Asthma Given in the Emergency Department - a Pilot Randomised Feasibility Trial of Dexamethasone in Children
| NCT ID | NCT07402707 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sheffield Children's NHS Foundation Trust |
| Condition | Acute Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 104 participants in total. It began in 2026-02-23 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Steroids given by mouth are an important first line treatment for children presenting with asthma attacks. Dexamethasone is the steroid used in some emergency departments (EDs) because of the need for a single dose and as it is well tolerated. The dose of dexamethasone in treating asthma attacks is not clearly established. This study compares two different doses of dexamethasone in children presenting with an asthma attack. Investigators will compare the effect of two different doses in reducing the need for a repeat prescription of steroids for an asthma attack in the 2 weeks after the first treatment. The investigators will also look at how often children attend the ED or their GP after being given treatment as well as the acceptability to parents and children. Although this study may provide an answer to the question of whether the different doses have the same effect, the investigators believe that a larger study will be needed to provide robust generalisable evidence, as well as to ensure that the outcomes are truly what matters to parents, children and healthcare professionals. This study will provide valuable information to enable a larger study to be undertaken.
Eligibility Criteria
Inclusion Criteria: * Children aged 4-15 years (inclusive) presenting to the ED with an asthma exacerbation, where oral steroids are recommended by Trust/National guidelines. * Children whose parents/carers do not speak English will also be eligible provided they speak one of the common languages where an interpreter and Information Sheets are available (Slovakian, Arabic and Urdu). Exclusion Criteria: * Children who have been treated with oral or IV steroids in the last 2 weeks. * Hypersensitivity to the study drug. * Children who have concomitant stridor. * First episode of wheezing (not previously diagnosed as asthma). * Children with known difficult asthma who receive longer courses of steroids as standard. * Life threatening episode of asthma. * Children with other conditions that require them to have steroids when unwell. * Children who are involved in current research or have recently been involved in research prior to recruitment
Contact & Investigator
Judith Gilchrist
PRINCIPAL INVESTIGATOR
Sheffield Children's NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07402707 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 15 Years, studying Acute Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07402707 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07402707 currently recruiting?
Yes, NCT07402707 is actively recruiting participants. Contact the research team at meena.balasubramanian@nhs.net for enrollment information.
Where is the NCT07402707 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT07402707 clinical trial?
NCT07402707 is sponsored by Sheffield Children's NHS Foundation Trust. The principal investigator is Judith Gilchrist at Sheffield Children's NHS Foundation Trust. The trial plans to enroll 104 participants.
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