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

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ClinicalTrials.gov Identifier: NCT03698630
Recruitment Status : Completed
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborators:
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin
Information provided by (Responsible Party):
University College Dublin

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

Condition or disease Intervention/treatment Phase
Asthma Acute Asthma Drug: Prednisolone Sodium Phosphate Drug: Dexamethasone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open-label, non-inferiority trial
Masking: Single (Outcomes Assessor)
Masking Description: The Pediatric Respiratory Assessment Measure score will be performed by a clinician blinded to treatment allocation.
Primary Purpose: Treatment
Official Title: Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the Emergency Department
Actual Study Start Date : July 6, 2011
Actual Primary Completion Date : July 13, 2012
Actual Study Completion Date : July 13, 2012


Arm Intervention/treatment
Experimental: Dexamethasone
Single dose of 0.3 mg/kg dexamethasone (rounded off to the nearest 2 mg, max. 12 mg) prescribed on day 1
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.

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
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.
Other Names:
  • Prednesol 5mg
  • Prednisolone




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Salbutamol therapies [ Time Frame: 14 days ]
    Frequency of salbutamol therapies given following enrolment

  3. 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.

  4. Incidence of vomiting [ Time Frame: 14 days ]
    Incidence of vomiting

  5. 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.



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698630


Locations
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Ireland
Our Lady's Children's Hospital, Crumlin
Dublin, Ireland
Sponsors and Collaborators
University College Dublin
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin

Publications:
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Responsible Party: University College Dublin
ClinicalTrials.gov Identifier: NCT03698630     History of Changes
Other Study ID Numbers: RESP_301_2010
2010-022001-18 ( EudraCT Number )
ISRCTN26944158 ( Registry Identifier: ISRCTN )
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College Dublin:
Asthma
Pediatric
Corticosteroid
Emergency department
Additional relevant MeSH terms:
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Prednisolone phosphate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents