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NCT Number: NCT07228052

Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Mustfa Manzur, MD MPH MS

CONTACT

[email protected]

718-920-6626

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone 16mg IM

Drug

Dexamethasone 16mg Intramuscular Administration Once

Prednisone 60mg PO

Drug

Prednisone 60mg PO for 5 Days

Primary outcomes

  1. Asthma Control Test Score

    Time frame: 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 outcomes

  1. ED or Hospitalization for Asthma

    Time frame: 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.

  2. 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

    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.

  3. Adverse Effects

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mustfa Manzur, MD MPH MS

CONTACT

[email protected]

718-920-6626

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Acronym: GASPING

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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