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.
Brief Title
Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-6626
Central Contact Email
mmanzur@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
ASTHMA
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
dexamethasone
prednisone
randomized controlled trial
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07228052
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2025-16648
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial
Primary Outcomes
Outcome Description
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.
Outcome Measure
Asthma Control Test Score
Outcome Time Frame
Within 4 Weeks post-discharge, up to 28-30 days
Secondary Ids
Secondary Id
2025
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Within 4 Weeks post-discharge, up to 28-30 days
Outcome Measure
ED or Hospitalization for Asthma
Outcome Description
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.
Outcome Time Frame
At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days
Outcome Measure
Change in Quality of Life
Outcome Description
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.
Outcome Time Frame
At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days
Outcome Measure
Adverse Effects
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Carlo Lutz
Investigator Email
clutz@montefiore.org
Investigator Department
Emergency Medicine
Investigator Sponsor Organization
Montefiore
Study Department
Emergency Medicine
Study Division
Not Applicable
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Immune System --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES
DEXAMETHASONE
PREDNISONE
PREGNADIENETRIOLS
PREGNADIENES
PREGNANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
STEROIDS, FLUORINATED
PREGNADIENEDIOLS