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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241006
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):
Matthew Rehrer, 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.

Condition or disease Intervention/treatment Phase
Asthma Reactive Airway Disease Drug: Dexamethasone Drug: Prednisone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma
Study Start Date : January 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Active Comparator: Dexamethasone
Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
Drug: Dexamethasone
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
Other Name: Decadron

Active Comparator: Prednisone
Prednisone 60mg PO capsules for 5 days
Drug: Prednisone
Prednisone 60mg PO q day for 5 days
Other Name: Glucocorticoid

Primary Outcome Measures :
  1. Relapse for worsening asthma within 14 days of ED visit [ Time Frame: 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 :
  1. Compliance [ Time Frame: 14 days ]
    Completion of study medications

  2. Side effects [ Time Frame: 14 days ]
    Assess if any side effects from the study medications

  3. Symptoms persistence or improvement [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241006

United States, California
Alameda County Medical Center
Oakland, California, United States, 94602
Sponsors and Collaborators
Alameda County Medical Center
Principal Investigator: Barry Simon, MD Alameda County Medica Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matthew Rehrer, Chairman of ACMC Emergency Department, Alameda County Medical Center Identifier: NCT01241006     History of Changes
Other Study ID Numbers: IRB10-08103G
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by Matthew Rehrer, Alameda County Medical Center:

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action