Acute Asthma, Asthma
Conditions
Keywords
Asthma, Pediatric, Corticosteroid, Emergency department
Brief 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.
Interventions
Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.
DRUGDexamethasone
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.
Sponsors
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The Pediatric Respiratory Assessment Measure score will be performed by a clinician blinded to treatment allocation.
Intervention model description
Randomized, open-label, non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Respiratory Assessment Measure score (PRAM) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 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 | 14 days | Frequency of salbutamol therapies given following enrolment |
| Compliance with medication as assessed by interview | 14 days | Incidence of compliance with medication with regards to taking 3 doses of the medication. |
| Incidence of vomiting | 14 days | Incidence of vomiting |
Countries
Ireland
Outcome results
None listed