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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 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
National Children's Research Centre
Our Lady's Children's Hospital, Crumlin
Information provided by (Responsible Party):
University College Dublin

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE July 6, 2011
Actual Primary Completion Date July 13, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children
Official Title  ICMJE Single Dose Oral Dexamethasone Versus Multi-dose Prednisolone in the Treatment of Acute Exacerbations of Asthma in Children Who Attend the 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Asthma
  • Acute Asthma
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Dexamethasone
    Single dose of 0.3 mg/kg dexamethasone (rounded off to the nearest 2 mg, max. 12 mg) prescribed on day 1
    Intervention: Drug: 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
    Intervention: Drug: Prednisolone Sodium Phosphate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2018)
250
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 13, 2012
Actual Primary Completion Date July 13, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698630
Other Study ID Numbers  ICMJE RESP_301_2010
2010-022001-18 ( EudraCT Number )
ISRCTN26944158 ( Registry Identifier: ISRCTN )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University College Dublin
Study Sponsor  ICMJE University College Dublin
Collaborators  ICMJE
  • National Children's Research Centre
  • Our Lady's Children's Hospital, Crumlin
Investigators  ICMJE Not Provided
PRS Account University College Dublin
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP