Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma

Conditions
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Asthma, Reactive Airway Disease

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules | Drug: Dexamethasone<br>* Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days<br>* Other names: Decadron;|
| Active Comparator: Prednisone<br>Prednisone 60mg PO capsules for 5 days | Drug: Prednisone<br>* Prednisone 60mg PO q day for 5 days<br>* Other names: Glucocorticoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse for worsening asthma within 14 days of ED visit | Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma | 14-17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Completion of study medications | 14 days | 
| Side effects | Assess if any side effects from the study medications | 14 days | 
| Symptoms persistence or improvement | Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living | 14-21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse, Corticosteroids