Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone 16mg IM
DrugDexamethasone 16mg Intramuscular Administration Once
Prednisone 60mg PO
DrugPrednisone 60mg PO for 5 Days
Treatment groups
182 Participants
are divided into 2 treatment groupsGroup A: Single Intramuscular Steroid InjectionActive comparator 1 intervention
Group B: Oral Steroid Short CourseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Asthma Control Test Score
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.
Time frame
Within 4 Weeks post-discharge, up to 28-30 daysSecondary outcomes
1
ED or Hospitalization for Asthma
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.
Time frame
Within 4 Weeks post-discharge, up to 28-30 days2
Change in Quality of Life
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.
Time frame
At 2 weeks (at approximately 14-15 days) and 4 weeks post-discharge relative to baseline, up to 28-30 days3
Adverse Effects
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.
Time frame
At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 daysSponsors and contacts
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Source ClinicalTrials.gov