A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- Relapse for worsening asthma within 14 days of ED visit
研究概览
简要总结
This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5 days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent relapse with an unscheduled return visit to a health care provider for additional asthma treatment within 14 days. The investigators hypothesize that the two treatments will be equally effective in relapse prevention.
详细描述
Dexamethasone and Prednisone are both systemic corticosteroids. The study will compare a single dose of oral dexamethasone to 5 days of oral prednisone in the treatment of asthma. Oral corticosteroids are commonly prescribed following an asthma exacerbation as it has been demonstrated that these medications prevent relapse.
Oral prednisone is the most common corticosteroid prescribed for asthma relapse prevention. The half life is around 4 hours and is typically prescribed for minimally 5 days.
The study is evaluating the efficacy of a single dose of dexmethasone. The drug's efficicacy has been shown to be longer acting and up to 72 hours. A single dose would eliminate the need for a prescription for a drug like prednisone to hopefully improve compliance.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55yo
- •History of asthma
- •Requires > 1 albuterol nebulizer
- •Valid phone number
排除标准
- •declines participation
- •Past allergic reaction to corticosteroids
- •Use of Oral steroids in the last 2 weeks
- •History of COPD, pulmonary fibrosis, cystic fibrosis, or other chronic lung disease
- •History of HIV
- •History of CHF
- •History of Diabetes mellitus
- •Active chickenpox (varicella) or shingles (herpes zoster)
- •Active TB
- •Requires admission to the Hospital
- •Requires immediate airway intervention
研究组 & 干预措施
Dexamethasone
Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
干预措施: Dexamethasone (Drug)
Prednisone
Prednisone 60mg PO capsules for 5 days
干预措施: Prednisone (Drug)
结局指标
主要结局
Relapse for worsening asthma within 14 days of ED visit
时间窗: 14-17 days
Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma
次要结局
- Compliance(14 days)
- Side effects(14 days)
- Symptoms persistence or improvement(14-21 days)
研究者
Matthew Rehrer
Chairman of ACMC Emergency Department
Alameda County Medical Center