Asthma
Conditions
Keywords
dexamethasone, prednisone, randomized controlled trial
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.
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.
Interventions
DRUGDexamethasone 16mg IM
Dexamethasone 16mg Intramuscular Administration Once
DRUGPrednisone 60mg PO
Prednisone 60mg PO for 5 Days
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned 1:1 to a treatment group using a computer-generated randomization schedule.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test Score | 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
| Measure | Time frame | Description |
|---|---|---|
| ED or Hospitalization for Asthma | 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. |
| Change in Quality of Life | 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. |
| Adverse Effects | 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. |
Countries
United States
Contacts
CONTACTMustfa Manzur, MD MPH MS
PRINCIPAL_INVESTIGATORCarlo Lutz, MD
Montefiore Medical Center
Outcome results
None listed