Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department

Not Applicable

Not yet recruiting

• Conditions: Asthma
• Interventions: Drug: Dexamethasone 16mg IM; Drug: Prednisone 60mg PO

• Registration Number: NCT07228052
• Lead Sponsor: Montefiore Medical Center

Brief Summary

This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations. This is a randomized, controlled, double-blind, non-inferiority trial conducted at two urban EDs within the Montefiore Health System.

Detailed Description

Asthma exacerbations are a leading cause of emergency department (ED) visits in the United States. In pediatric patients, a single dose of dexamethasone has been widely adopted as an effective and convenient alternative to multi-day oral steroid regimens. However, in adults, evidence regarding the efficacy of a single-dose steroid approach compared to a traditional 5-day course of oral prednisone is mixed. Despite the availability of oral corticosteroids like prednisone, medication adherence after ED discharge remains a significant challenge. Studies indicate that only about 30% of ED patients fill prescribed medications post-discharge. A single-dose intramuscular (IM) dexamethasone regimen offers the advantage of ensuring adequate anti-inflammatory effects for asthma exacerbations. This study aims to compare the efficacy of a one-time IM dose of dexamethasone versus a 5-day course of prednisone in adult ED patients presenting with asthma exacerbations.

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-12
• Study First Submitted QC: 2025-11-12
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-13
• Last Update Posted: 2025-11-13
• Study Start: 2026-01-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Adults ≥18 years old presenting to the ED with an asthma exacerbation
• Diagnosed with asthma per International Classification of Diseases, 10th Revision (ICD-10) criteria or by the treating clinician
• Discharged from the ED with a primary diagnosis of asthma exacerbation
• Initiated systemic corticosteroids during the ED visit
• Must be English or Spanish speaking

Exclusion Criteria

• Current use of systemic corticosteroids, including Emergency Medical Services (EMS) administration before ED arrival
• History of severe adverse reactions to corticosteroids
• Heart failure and uncontrolled diabetes (glucose >300mg/dL in the ED)
• Pregnancy or breastfeeding as prednisone is the preferred treatment for asthma in this population
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Intramuscular Steroid Injection	Dexamethasone 16mg IM	Dexamethasone 16mg Intramuscular Single Dose
Oral Steroid Short Course	Prednisone 60mg PO	Prednisone 60mg PO for 5 Days

Primary Outcome Measures

Name	Time	Method
Asthma Control Test Score	Within 4 Weeks post-discharge, up to 28-30 days	Asthma control will be assessed via administration of the Asthma Control Test (ACT) questionnaire at 4 weeks post-discharge. The ACT questionnaire is comprised of 5 questions which ask participants to recall how asthma symptoms have affected them over the prior 4 weeks. Responses to the 5 questions are rated on a 5-point Likert scale ranging from 1-5, yielding an overall possible scoring range of 5-25. Higher ACT scores are indicative of better asthma control. For this study, an ACT score \>19 indicates well-controlled asthma. Scores will be summarized by study arm using basic descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
ED or Hospitalization for Asthma	Within 4 Weeks post-discharge, up to 28-30 days	The number of return visits to the ED or hospitalizations related to asthma, within 30 days post-discharge, will be summarized by study arm using basic descriptive statistics.
Change in Quality of Life	At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days	Change in Quality of Life will be measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ). The MiniAQLQ is a 21-item survey which consists of questions spanning four domains: symptoms, activity limitations, emotional function, and environmental stimuli, in order to understand how asthma affects patients in daily life. Responses to the first 15 questions are rated on a 7-point scale ranging from 1-7, questions 16-20 are rated using a 3-point scale ranging from 1-3, and question 21 is rated on 0-10 scale, with higher scores being indicative of a better quality of life, yielding an overall possible scoring range of 20-130. Scores will be summarized by study arm.
Adverse Effects	At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days	Documented occurrence of Adverse Effects, including nausea, headache, rash, or Serious Adverse Events, as defined by International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, will be summarized by study arm.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 The Bronx, New York, United States