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 is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Alameda County Medical Center
Sponsor:
Information provided by (Responsible Party):
Matthew Rehrer, Alameda County Medical Center
ClinicalTrials.gov Identifier:
NCT01241006
First received: November 15, 2010
Last updated: July 14, 2014
Last verified: July 2014

November 15, 2010
July 14, 2014
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
 
A Randomized Double-Blind Controlled Trial of Single Oral Dose Dexamethasone Versus Five Days of Oral Prednisone in Acute Mild to Moderate 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.

Not Provided
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
  • Drug: Prednisone
    Prednisone 60mg PO q day for 5 days
  • 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.
 
Recruiting
480
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
No
Contact: Matthew Rehrer, MD 510-437-4564 matthewrehrer@gmail.com
United States
 
NCT01241006
IRB10-08103G
Yes
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
July 2014

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