Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children
Condition: Asthma; Acute Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A trial to investigate if a single dose of the oral corticosteroid, Dexamethasone is as
      effective in treating exacerbations of asthma in children as 3 days of treatment with another
      oral corticosteroid, Prednisolone
    

Detailed description: 
      Asthma is a major cause of pediatric morbidity and mortality. In acute exacerbations of
      asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for
      ß2-agonist therapy. Prednisolone is relatively short-acting with a half-life of 12 to 36
      hours, thereby requiring daily dosing. Prolonged treatment course, vomiting and a bitter
      taste may reduce patient compliance with prednisolone. Dexamethasone is a long-acting
      corticosteroid with a half-life of 36 to 72 hours. It is used frequently in children with
      croup and bacterial meningitis, and is well absorbed orally. The purpose of this trial is to
      examine whether a single dose of oral dexamethasone (0.3 mg/kg) is clinically non-inferior to
      prednisolone (1 mg/kg/day for three days) in the treatment of exacerbations of asthma in
      children who attend the Emergency Department.

      This is a randomized, non-inferiority, open-label clinical trial. After informed consent with
      or without assent, patients will be randomized to either oral dexamethasone 0.3 mg/kg stat or
      prednisolone 1 mg/kg/day for three days. The primary outcome measure is the comparison
      between the Pediatric Respiratory Assessment Measure (PRAM) across both groups on Day 4. The
      PRAM score, a validated, responsive and reliable tool to determine asthma severity in
      children aged 2 to 16 years, will be performed by a clinician blinded to treatment
      allocation. Secondary outcomes include relapse, hospital admission and requirement for
      further steroid therapy. Data will be analyzed on an intention-to-treat and a per protocol
      basis. With a sample size of 232 subjects (105 in each group with an estimated 10% loss to
      follow-up), we will be able to reject the null hypothesis - that the population means of the
      experimental and control groups are equal with a power of 0.9. The Type I error probability
      associated with this test (of the null hypothesis) is 0.05.

      This clinical trial may provide evidence that a shorter steroid course using dexamethasone
      can be used in the treatment of acute pediatric asthma, thus eliminating the issue of
      compliance to treatment.
    

Intervention name(s): Prednisolone Sodium Phosphate; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.; Dexamethasone 2 mg tablets (Organon Ireland Ltd). Round, 6 mm, flat, white tablet with the code "XC/8" engraved on one surface and "Organon*" on the other containing 2 mg dexamethasone.
Other intervention name(s): Prednesol 5mg; Prednisolone
Intervention MeSH terms: Dexamethasone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open-label, non-inferiority trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Pediatric; Corticosteroid; Emergency department