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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-05-31

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.

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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.

Conditions

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Asthma Reactive Airway Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days

Prednisone

Prednisone 60mg PO capsules for 5 days

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

Prednisone 60mg PO q day for 5 days

Interventions

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Dexamethasone

Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days

Intervention Type DRUG

Prednisone

Prednisone 60mg PO q day for 5 days

Intervention Type DRUG

Other Intervention Names

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Decadron Glucocorticoid

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No