Giving Asthmatics Intramuscular Steroids for Preventing Return to the Emergency Department: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Asthma Control Test Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral Steroid Short Course
Prednisone 60mg PO for 5 Days
干预措施: Prednisone 60mg PO (Drug)
Single Intramuscular Steroid Injection
Dexamethasone 16mg Intramuscular Single Dose
干预措施: Dexamethasone 16mg IM (Drug)
结局指标
主要结局
Asthma Control Test Score
时间窗: 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.
次要结局
- ED or Hospitalization for Asthma(Within 4 Weeks post-discharge, up to 28-30 days)
- 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)
- Adverse Effects(At Day 0 and 4-weeks post-discharge relative to baseline, up to 28-30 days)