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
  Purpose

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
Asthma
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


Estimated Enrollment: 480
Study Start Date: January 2011
Estimated Study Completion Date: May 2015
Estimated 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
Active Comparator: Prednisone
Prednisone 60mg PO capsules for 5 days
Drug: Prednisone
Prednisone 60mg PO q day for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01241006

Contacts
Contact: Matthew Rehrer, MD 510-437-4564 matthewrehrer@gmail.com

Locations
United States, California
Alameda County Medical Center Recruiting
Oakland, California, United States, 94602
Contact: Matthew Rehrer, MD    510-437-4564    matthewrehrer@gmail.com   
Sponsors and Collaborators
Alameda County Medical Center
Investigators
Principal Investigator: Barry Simon, MD Alameda County Medica Center
  More Information

No publications provided

Responsible Party: Matthew Rehrer, Chairman of ACMC Emergency Department, Alameda County Medical Center
ClinicalTrials.gov Identifier: NCT01241006     History of Changes
Other Study ID Numbers: IRB10-08103G
Study First Received: November 15, 2010
Last Updated: July 14, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alameda County Medical Center:
Relapse
Corticosteroids

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014