Clinical trial NCT01241006: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Reactive Airway Disease
Keywords: Relapse
Corticosteroids
Lead sponsor: Alameda County Medical Center
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relapse for worsening asthma within 14 days of ED visit
timeFrame: 14-17 days
Secondary outcomes:
measure: Compliance
timeFrame: 14 days
measure: Side effects
timeFrame: 14 days
measure: Symptoms persistence or improvement
timeFrame: 14-21 days
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Alameda County Medical Center
state: California
Study officials:
affiliation: Alameda County Medica Center
name: Barry Simon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.