Asthma, Reactive Airway Disease
Conditions
Keywords
Relapse, Corticosteroids
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexamethasone
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
DRUGPrednisone
Prednisone 60mg PO q day for 5 days
Sponsors
Alameda County Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-55yo * History of asthma * Requires \> 1 albuterol nebulizer * Valid phone number
Exclusion criteria
* declines participation * Past allergic reaction to corticosteroids * Use of Oral steroids in the last 2 weeks * Pregnant * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse for worsening asthma within 14 days of ED visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 14 days | Completion of study medications |
| Side effects | 14 days | Assess if any side effects from the study medications |
| Symptoms persistence or improvement | 14-21 days | Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living |
Countries
United States
Outcome results
None listed