One-dose dexamethasone vs five-day prednisone for adults with asthma in the ED

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, non-inferiority study compares a one-time IM dose of dexamethasone (16 mg) with a five-day oral prednisone course (60 mg total) for adults discharged from the ED after an asthma exacerbation. Conducted at two urban EDs within the Montefiore Health System, the trial aims to determine if the single-dose regimen provides similar control of symptoms and readmission risk as the standard five-day prednisone regimen. Eligibility includes adults 18 and older with an asthma flare who were treated with systemic corticosteroids in the ED and discharged, with only English or Spanish speakers included. Key exclusions include prior systemic corticosteroid use before arrival, certain comorbidities, pregnancy, and inability to consent. The study addresses adherence challenges seen with post-discharge oral steroids by testing a regimen that ensures effective anti-inflammatory exposure with a single dose.

Why it matters

Who can join: the full rules

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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Carlo Lutz, MD — Montefiore Medical Center
• Study coordinator: Mustfa Manzur, MD MPH MS
• Email: mmanzur@montefiore.org
• Phone: 718-920-6626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.