Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department

Official title

Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial

Overview

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.

Interventions

• Drug Dexamethasone 16mg IM
  Dexamethasone 16mg Intramuscular Administration Once
• Drug Prednisone 60mg PO
  Prednisone 60mg PO for 5 Days

Primary outcome measures

• Asthma Control Test Score [Time frame: Within 4 Weeks post-discharge, up to 28-30 days]

Secondary outcome measures (3)

• ED or Hospitalization for Asthma [Time frame: Within 4 Weeks post-discharge, up to 28-30 days]
• Change in Quality of Life [Time frame: At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days]
• Adverse Effects [Time frame: At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Montefiore Medical Center — The Bronx

Publications

• Hasegawa K, Craig SS, Teach SJ, Camargo CA Jr. Management of Asthma Exacerbations in the Emergency Department. J Allergy Clin Immunol Pract. 2021 Jul;9(7):2599-2610. doi: 10.1016/j.jaip.2020.12.037. Epub 2020 Dec 31. PMID 33387672
• Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10. PMID 24515516
• Kirkland SW, Cross E, Campbell S, Villa-Roel C, Rowe BH. Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma. Cochrane Database Syst Rev. 2018 Jun 2;6(6):CD012629. doi: 10.1002/14651858.CD012629.pub2. PMID 29859017
• Fischer MA, Jones JB, Wright E, Van Loan RP, Xie J, Gallagher L, Wurst AM, Shrank WH. A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm. 2015 Feb;21(2):124-31. doi: 10.18553/jmcp.2015.21.2.124. PMID 25615001
• Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821. PMID 17726409
• Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021. PMID 11445789
• Nelsen LM, Kosinski M, Rizio AA, Jacques L, Schatz M, Stanford RH, Svedsater H. A structured review evaluating content validity of the Asthma Control Test, and its consistency with U.S. guidelines and patient expectations for asthma control. J Asthma. 2022 Mar;59(3):628-637. doi: 10.1080/02770903.2020.1861624. Epub 2020 Dec 30. PMID 33377411
• Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x. PMID 10489826

Identifiers

NCT: NCT07228052 · 2025-16648

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗