NCT07402707

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
4mo left

Started Feb 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

February 18, 2025

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 23, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 18, 2025

Last Update Submit

April 20, 2026

Conditions

Acute AsthmaDexamethasone

Keywords

Dexamethasone

Outcome Measures

Primary Outcomes (1)

  • Participant recruitment

    The primary outcomes will be recruitment rate and time, attrition, willingness to be randomised, completion and follow-up rates

    7 months

Secondary Outcomes (5)

  • Tolerability

    7 months

  • Tolerability

    7 months

  • Tolerability

    7 months

  • Tolerability

    7 months

  • Hospital Admission

    7 months

Study Arms (2)

0.3mg dose

OTHER

Lower dose of dexamethasone

Drug: dexamethasone oral

0.6mg

OTHER

Lower dose of dexamethasone

Drug: dexamethasone oral

Interventions

dexamethasone oralDRUG

The interventions are Dexamethasone, 0.3mg/kg versus 0.6 mg/kg

0.3mg dose0.6mg

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Children's NHS Foundation Trust

Sheffield, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Judith Gilchrist

    Sheffield Children's NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meena Balasubramanian

CONTACT

0114 3053136meena.balasubramanian@nhs.net

Gillian Gatenby

CONTACT

0114 3053136gillian.gatenby@nhs.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 11, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 23, 2026

Record last verified: 2026-02

Locations

GB(1)