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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241006
• Other study ID #: IRB10-08103G
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2010
• Last updated: January 5, 2016
• Start date: January 2011
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Alameda County Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity
• Reactive Airway Disease

Intervention

Drug:
• Dexamethasone
Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
• Prednisone
Prednisone 60mg PO q day for 5 days

Locations

Country	Name	City	State
United States	Alameda County Medical Center	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Alameda County Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14-17 days	No
Secondary	Compliance	Completion of study medications	14 days	No
Secondary	Side effects	Assess if any side effects from the study medications	14 days	Yes
Secondary	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	14-21 days	No