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

This study has been completed.
Information provided by (Responsible Party):
Matthew Rehrer, Alameda County Medical Center Identifier:
First received: November 15, 2010
Last updated: January 5, 2016
Last verified: January 2016
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 Intervention Phase
Reactive Airway Disease
Drug: Dexamethasone
Drug: Prednisone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Alameda County Medical Center:

Primary Outcome Measures:
  • Relapse for worsening asthma within 14 days of ED visit [ Time Frame: 14-17 days ] [ Designated as safety issue: No ]
    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:
  • Compliance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Completion of study medications

  • Side effects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Assess if any side effects from the study medications

  • Symptoms persistence or improvement [ Time Frame: 14-21 days ] [ Designated as safety issue: No ]
    Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living

Enrollment: 376
Study Start Date: January 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Matthew Rehrer, Chairman of ACMC Emergency Department, Alameda County Medical Center Identifier: NCT01241006     History of Changes
Other Study ID Numbers: IRB10-08103G 
Study First Received: November 15, 2010
Last Updated: January 5, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016