Recruiting

Dexamethasone vs. Prednisone

Sponsor:

Montefiore Medical Center

Code:

NCT07228052

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone 16mg IM

Prednisone 60mg PO

Study Details

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.

Conditions

Asthma

Study ID

NCT07228052

Start date

Jul 23, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Single Intramuscular Steroid Injection

Dexamethasone 16mg Intramuscular Single Dose

active comparator: Oral Steroid Short Course

Prednisone 60mg PO for 5 Days

Interventions

Dexamethasone 16mg IM

Dexamethasone 16mg Intramuscular Administration Once

Prednisone 60mg PO

Prednisone 60mg PO for 5 Days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mustfa Manzur, MD MPH MS

718-920-6626mmanzur@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Mustfa Manzur, MD MPH MS

718-920-6626mmanzur@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • dexamethasone
  • prednisone
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-07-24.