Oral Prednisolone Dosing in Children Hospitalized With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study hopes to determine the appropriate oral steroid dose for treating children
      hospitalized with asthma exacerbations. Practice guidelines from different countries
      recommend a wide range of doses, and the doses used in actual practice vary widely. There is
      no data on what is the most appropriate dose of prednisone (or equivalent) in this situation.
      We will be looking at the dose recommended by the National Asthma Education and Prevention
      Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as
      compared with a lower dose which is commonly used in practice. We hypothesize that the lower
      dose will be no worse than the higher dose as determined primarily by duration of
      hospitalization.
    

Detailed description: 
      Practice guidelines for the management of asthma in children universally recommend systemic
      corticosteroids for the treatment of moderate to severe asthma exacerbations. However, these
      guidelines vary widely with respect to dose, frequency, method of delivery, and duration of
      therapy. In actual practice, there is also considerable variation among clinicians in terms
      of corticosteroid dosing in children hospitalized with asthma exacerbations. At the
      Children's Hospital of Philadelphia (CHOP) the current standard is to use an initial dose of
      4.0 mg/kg/day (1.0 mg/kg every 6 hours to a maximum of 30 mg/dose) although many other
      pediatric hospitals use a 2.0 mg/kg/day dose (1.0 mg/kg every 12 hours to a maximum of 30
      mg/dose). Systematic reviews of the literature have called for a clinical trial to evaluate
      the effect of different doses of corticosteroids in treating pediatric asthma patients
      hospitalized with exacerbations.

      This study will use a randomized, double-blind, controlled trial design in order to compare
      the efficacy of two different steroid doses in resolving acute exacerbations of asthma in
      hospitalized children. Children being hospitalized for asthma exacerbations from the CHOP
      emergency department (ED) will be eligible for study enrollment. Those that meet enrollment
      criteria will be randomized to receive prednisolone either in the higher dose (1.0 mg/kg (max
      30 mg) every 6 hours), or the lower dose (1.0 mg/kg (max 30 mg) every 12 hours and placebo
      doses at 6 hour intervals in between) for the first 48 hours of hospitalization. Once 48
      hours has past, all patients still hospitalized will receive 1.0 mg/kg (max 30 mg) every 12
      hours for the duration of hospitalization. Approximately 156 patients with 78 in each arm of
      the study will be enrolled. This study should be completed in six to eight months. A
      non-inferiority study design will be used. The primary outcome will be duration of
      hospitalization, as determined by duration of time elapsed from first dose of prednisolone
      administered in the emergency department (ED) until the discharge dose of albuterol is
      administered. Secondary outcomes will include time elapsed from the time the admission order
      is written until the discharge order is written, time spent in each severity level of the
      asthma care pathway, degree and rate of improvement in forced expiratory volume in one second
      (FEV1), improvement in peak expiratory flows (PEF), improvement in asthma symptom scores, and
      rate of relapse after discharge.
    

Intervention name(s): Prednisolone high dose; Prednisolone lower dose
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose); 2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
Other intervention name(s): High Dose Prednisolone; Oral steriod; corticosteriods; asthma exacerbations; Low dose Prednisolone; Oral prednisolone; Oral steriod; corticosteriods; asthma exacerbations
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Corticosteroids; Treatment; Pediatric