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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthew Rehrer, Alameda County Medical Center
ClinicalTrials.gov Identifier:
NCT01241006
First received: November 15, 2010
Last updated: January 5, 2016
Last verified: January 2016

November 15, 2010
January 5, 2016
January 2011
May 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01241006 on ClinicalTrials.gov Archive Site
  • 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
  • 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: 14-17 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
Not Provided
Not Provided
 
Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma
A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate Adult Asthma
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • Reactive Airway Disease
  • Drug: Dexamethasone
    Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
    Other Name: Decadron
  • Drug: Prednisone
    Prednisone 60mg PO q day for 5 days
    Other Name: Glucocorticoid
  • Active Comparator: Dexamethasone
    Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
    Intervention: Drug: Dexamethasone
  • Active Comparator: Prednisone
    Prednisone 60mg PO capsules for 5 days
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
376
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241006
IRB10-08103G
Yes
Not Provided
Not Provided
Matthew Rehrer, Alameda County Medical Center
Alameda County Medical Center
Not Provided
Principal Investigator: Barry Simon, MD Alameda County Medica Center
Alameda County Medical Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP