A double-blinded non-inferiority randomised controlled trial of 1- versus 3-days of oral prednisolone for preschool children with moderate to severe exacerbations of asthma/wheeze

A 22 day prospective, multi-centre, double-blind non-inferiority phase III randomised controlled trial in children aged 24 to 59 months with moderate to severe asthma presenting to Emergency Departments evaluating if a single dose of oral prednisolone is as effective as a three-day course for prevention of moderate/severe outcomes, including recrudescence of symptoms and/or deterioration in clinical condition in the first seven days following treatment.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001112459

Acronym

STAR: STeroids in preschool Asthma Reduction study

Enrollment

1074

Registered

2025-10-13

Start date

2025-10-20

Completion date

2028-10-20

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This randomised controlled trial aims to determine if one day of oral prednisolone for preschool children with moderate to severe wheeze is non-inferior to the standard three days of treatment. We will compare outcomes between two preschool asthma treatment arms in 1074 children to find out if reducing the course of treatment from three days to one day of oral prednisolone is just as safe. Eligible participants will be recruited as sites in New Zealand and Australia and randomised to either standard treatment of three days of oral steroid or one day of oral steroid and two days of placebo.

Interventions

Intervention arm regimen: Open-label oral liquid prednisolone >= 1 mg/kg (rounded up to nearest mg) on day 1, followed by oral liquid placebo (identical in colour, taste, volume and viscosity to prednisolone) on days 2 and 3 Adherence will be monitored by parental report in follow up surveys and review of medication charts for participants who are admitted.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

24 Months to 59 Months

Healthy volunteers

Inclusion criteria

Primary presentation to ED with moderate/severe wheezy respiratory illness (viral induced wheeze or preschool asthma); AND Patient has received >=1mg/kg oral prednisolone within the last 12 hours in ED or the community.

Exclusion criteria

Unable to be followed up at 8 days; Prednisolone in the previous 7 days, unless within 12 hours of presentation; Oral dexamethasone, or systemic hydrocortisone in the previous 7 days; Current or previous life-threatening asthma (ICU admission or IV treatment); Chronic respiratory or cardiac disease, not including asthma/wheeze; Previous enrolment; Insurmountable language barrier; OR Unable to consent within 12 hours of oral prednisolone dose

Outcome results