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NCT Number: NCT01241006

Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days

Other names: Decadron

Prednisone

Drug

Prednisone 60mg PO q day for 5 days

Other names: Glucocorticoid

Primary outcomes

  1. Relapse for worsening asthma within 14 days of ED visit

    Time frame: 14-17 days

    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 outcomes

  1. Compliance

    Time frame: 14 days

    Completion of study medications

  2. Side effects

    Time frame: 14 days

    Assess if any side effects from the study medications

  3. Symptoms persistence or improvement

    Time frame: 14-21 days

    Assessment of current rescue inhaler use and symptoms such as wheezing, cough, shortness of breath, and difficulty with activities of daily living

Sponsors and collaborators

Lead sponsor

Alameda County Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2010
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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