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Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department

NCT ID: NCT07228052

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-30

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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dexamethasone prednisone randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Participants, treating physicians, nursing, and the investigators will remain blinded to treatment allocation. Blinded medications will be pre-packaged by the clinical research pharmacy team.

Study Groups

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Single Intramuscular Steroid Injection

Dexamethasone 16mg Intramuscular Single Dose

Group Type ACTIVE_COMPARATOR

Dexamethasone 16mg IM

Intervention Type DRUG

Dexamethasone 16mg Intramuscular Administration Once

Oral Steroid Short Course

Prednisone 60mg PO for 5 Days

Group Type ACTIVE_COMPARATOR

Prednisone 60mg PO

Intervention Type DRUG

Prednisone 60mg PO for 5 Days

Interventions

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Dexamethasone 16mg IM

Dexamethasone 16mg Intramuscular Administration Once

Intervention Type DRUG

Prednisone 60mg PO

Prednisone 60mg PO for 5 Days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlo Lutz, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Central Contacts

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Mustfa Manzur, MD MPH MS

Role: CONTACT

Phone: 718-920-6626

Email: [email protected]

Facility Contacts

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Mustfa Manzur, MD MPH MS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 11445789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33387672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24515516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29859017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25615001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17726409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33377411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10489826 (View on PubMed)

Alzahrani YA, Becker EA. Asthma Control Assessment Tools. Respir Care. 2016 Jan;61(1):106-16. doi: 10.4187/respcare.04341. Epub 2015 Nov 10.

Reference Type BACKGROUND
PMID: 26556901 (View on PubMed)

Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.

Reference Type BACKGROUND
PMID: 19767070 (View on PubMed)

Other Identifiers

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2025-16648

Identifier Type: -

Identifier Source: org_study_id