NCT01241006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

November 15, 2010

Last Update Submit

January 5, 2016

Conditions

AsthmaReactive Airway Disease

Keywords

RelapseCorticosteroids

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Compliance

    14 days

  • Side effects

    14 days

  • Symptoms persistence or improvement

    14-21 days

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Prednisone

ACTIVE COMPARATOR

Prednisone 60mg PO capsules for 5 days

Drug: Prednisone

Interventions

DexamethasoneDRUG

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

Also known as: Decadron
Dexamethasone
PrednisoneDRUG

Prednisone 60mg PO q day for 5 days

Also known as: Glucocorticoid
Prednisone

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55yo
  • History of asthma
  • Requires \> 1 albuterol nebulizer
  • Valid phone number

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alameda County Medical Center

Oakland, California, 94602, United States

Location

Related Publications (1)

  • 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.

    PMID: 27117874DERIVED

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveRecurrence

Interventions

DexamethasoneCalcium DobesilatePrednisoneGlucocorticoids

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPregnadienediolsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Barry Simon, MD

    Alameda County Medica Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of ACMC Emergency Department

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)