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

NCT03698630 | Completed Phase 4

• 3 other identifiers: RESP_301_20102010-022001-18ISRCTN26944158
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma; Acute Asthma

Keywords

Asthma; Pediatric; Corticosteroid; Emergency department

Outcome Measures

Primary Outcomes (1)

• Pediatric Respiratory Assessment Measure score (PRAM) score

  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.

  Day 4

Secondary Outcomes (5)

• Relapse rate

  14 days

• Salbutamol therapies

  14 days

• Compliance with medication as assessed by interview

  14 days

• Incidence of vomiting

  14 days

• Relapse rate

  14 days

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Prednisolone

ACTIVE COMPARATOR

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

Interventions

Prednisolone Sodium Phosphate DRUG

Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.

Also known as: Prednesol 5mg, Prednisolone

Prednisolone

Dexamethasone DRUG

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.

Dexamethasone

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• National Children's Research Centre: collaborator
• Our Lady's Children's Hospital, Crumlin: collaborator

Study Sites (1)

Our Lady's Children's Hospital, Crumlin

Dublin, Ireland

Location

Related Publications (1)

• Cronin J, Kennedy U, McCoy S, An Fhaili 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.

  PMID: 22909281 BACKGROUND

MeSH Terms

Conditions

Asthma; Emergencies

Interventions

prednisolone phosphate; Methylprednisolone; Prednisolone; Dexamethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Pediatric Respiratory Assessment Measure score will be performed by a clinician blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, non-inferiority trial

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: October 9, 2018
• Study Start: July 6, 2011
• Primary Completion: July 13, 2012
• Study Completion: July 13, 2012
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

IE (1)