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

Phase 4

Completed

• Conditions: Asthma; Reactive Airway Disease
• Interventions: Drug: Dexamethasone; Drug: Prednisone

• Registration Number: NCT01241006
• Lead Sponsor: Alameda County Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• Age 18-55yo
• History of asthma
• Requires > 1 albuterol nebulizer
• Valid phone number

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
Prednisone	Prednisone	Prednisone 60mg PO capsules for 5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Alameda County Medical Center; 🇺🇸 Oakland, California, United States