The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.
Who can participate
Age range
2 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Aged between 2 and 18 years.
History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.
Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure \[PRAM\] score ≥8).
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Exclusion Criteria: Patients with suspected or confirmed foreign body aspiration.
Patients with concurrent croup.
Presence of comorbidities (cardiovascular, neurological, malignancy, chronic kidney or lung disease).
Patients with pneumonia.
Patients with air leaks (pneumothorax, pneumomediastinum).
Patients requiring immediate Intensive Care Unit (ICU) admission.
Systemic steroid use within the last 8 weeks.
Failure to obtain informed consent.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared IV dexamethasone to IV methylprednisolone for severe asthma attacks in children — since the trial is already completed, has my child's doctor seen or reviewed any of its findings, and could those results influence which steroid they'd choose if my child needed IV treatment?
2The trial measured a score called the PRAM at the 4th hour of treatment and again on the 2nd day after discharge — what does that score actually measure, and is it something you'd use to track my child's progress during a severe asthma episode?
3Since this was a Phase 4 trial, both drugs were already approved and in use — does that mean there's a well-established safety profile for both, and are there any differences in side effects between dexamethasone and methylprednisolone that I should know about for a child?
4This trial focused specifically on children with status asthmaticus, which is a severe, prolonged asthma attack — given my child's asthma history, is my child's condition similar enough that the findings from this trial would even be relevant to their care?
5The trial tracked kids after they went home, measuring their breathing score on day 2 post-discharge — what warning signs should I watch for at home after a severe asthma episode, and how does the steroid my child receives in the hospital affect their recovery once we leave?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour
Timeframe: At 4 hours after the initiation of treatment in the emergency department.
2
PRAM Score on the 2nd Day Post-Discharge
Timeframe: 2 days after discharge from the hospital