Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children

Overview

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

Full Title of Study: “Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 13, 2012

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.

Interventions

  • Drug: Prednisolone Sodium Phosphate
    • Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.
  • Drug: Dexamethasone
    • 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.

Arms, Groups and Cohorts

  • Experimental: Dexamethasone
    • Single dose of 0.3 mg/kg dexamethasone (rounded off to the nearest 2 mg, max. 12 mg) prescribed on day 1
  • Active Comparator: Prednisolone
    • 1 mg/kg prednisolone (rounded off to the nearest 5 mg, max. 40 mg) prescribed daily for three days from day 1

Clinical Trial Outcome Measures

Primary Measures

  • Pediatric Respiratory Assessment Measure score (PRAM) score
    • Time Frame: Day 4
    • Pediatric Respiratory Assessment Measure score (PRAM) on Day 4. This is a compound score ranging from 0 to 12 that measures asthma severity by accounting for oxygen saturation, the presence of suprasternal retractions and/or Scalene muscle contractions, the degree of air entry and presence/type of wheezing. A score of 0-3 indicates mild asthma, 4-7 moderate asthma and 8-12 severe asthma.

Secondary Measures

  • Relapse rate
    • Time Frame: 14 days
    • Rate of relapse as defined as any visit to a healthcare provide as a result of asthma symptoms within 14 days of study enrollment
  • Salbutamol therapies
    • Time Frame: 14 days
    • Frequency of salbutamol therapies given following enrolment
  • Compliance with medication as assessed by interview
    • Time Frame: 14 days
    • Incidence of compliance with medication with regards to taking 3 doses of the medication.
  • Incidence of vomiting
    • Time Frame: 14 days
    • Incidence of vomiting
  • Relapse rate
    • Time Frame: 14 days
    • Relapse will be defined as any visit to a healthcare provider, for example, General Practitioner, ED, as a result of asthma symptoms.

Participating in This Clinical Trial

Inclusion Criteria

  • Ages 2 to 16 years – Background history of asthma as defined by at least one previous episode of ß2-agonist-responsive wheeze in a child two years of age or over or a prior diagnosis of asthma, made by a pediatrician, or clinician of comparable experience – Presentation with an asthma exacerbation as defined as acute asthma, which prompts assessment at the ED, and has any, or all, of the following clinical features: Dyspnea, Wheeze, Acute cough, Increased work of breathing, Increased requirement for ß2-agonist from baseline use or O2 saturation <95% Exclusion Criteria:

  • Less than 2 years old or over 16 years – Critical or life-threatening asthma (as defined below) – Known TB exposure – Active varicella or herpes simplex infection – Documented concurrent infection with RSV – Fever >39.5°C – Use of oral corticosteroids in the previous four weeks – Concurrent stridor – Galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption – Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University College Dublin
  • Collaborator
    • National Children’s Research Centre
  • Provider of Information About this Clinical Study
    • Sponsor

References

Cronin J, Kennedy U, McCoy S, An Fhailí SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R. Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial. Trials. 2012 Aug 21;13:141. doi: 10.1186/1745-6215-13-141.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.