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

Primary Purpose

Asthma, Reactive Airway Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Prednisone
Sponsored by
Alameda County Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Relapse, Corticosteroids

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alameda County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexamethasone

Prednisone

Arm Description

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

Prednisone 60mg PO capsules for 5 days

Outcomes

Primary Outcome Measures

Relapse for worsening asthma within 14 days of ED visit
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
Completion of study medications
Side effects
Assess if any side effects from the study medications
Symptoms persistence or improvement
Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living

Full Information

First Posted
November 15, 2010
Last Updated
January 5, 2016
Sponsor
Alameda County Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01241006
Brief Title
Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alameda County Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Reactive Airway Disease
Keywords
Relapse, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Single dose of Dexamethasone 12 mg PO and 4 days of placebo capsules
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone 60mg PO capsules for 5 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Glucocorticoid
Intervention Description
Prednisone 60mg PO q day for 5 days
Primary Outcome Measure Information:
Title
Relapse for worsening asthma within 14 days of ED visit
Description
Relapse will be defined as un unscheduled visit to see a doctor for worsening asthma within 14 days following their ED visit for asthma
Time Frame
14-17 days
Secondary Outcome Measure Information:
Title
Compliance
Description
Completion of study medications
Time Frame
14 days
Title
Side effects
Description
Assess if any side effects from the study medications
Time Frame
14 days
Title
Symptoms persistence or improvement
Description
Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living
Time Frame
14-21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Simon, MD
Organizational Affiliation
Alameda County Medica Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alameda County Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27117874
Citation
Rehrer MW, Liu B, Rodriguez M, Lam J, Alter HJ. A Randomized Controlled Noninferiority Trial of Single Dose of Oral Dexamethasone Versus 5 Days of Oral Prednisone in Acute Adult Asthma. Ann Emerg Med. 2016 Nov;68(5):608-613. doi: 10.1016/j.annemergmed.2016.03.017. Epub 2016 Apr 22.
Results Reference
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Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma

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