Phase 3 N=97 Randomized Quadruple-blind Treatment

Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT02725008 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Feb 2019

Primary outcome: Primary: Treatment Failure — 6; 3 Participants — p=0.3

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dexamethasone (Drug); placebo (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Geoffrey W Jara-Almonte
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Failure	6; 3	0.3
SECONDARY Change in Symptom Severity From Day 1 to Day 5	-4; -4	0.95

Summary

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Eligibility Criteria

Inclusion Criteria

History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion Criteria

pregnancy
severe chronic cardiac, respiratory, neurological or neuromuscular disease
complete resolution of symptoms after one treatment of beta agonists
severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02725008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.