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Clinical Trials/NCT02499887
NCT02499887
Terminated
Not Applicable

Repeat Emergency Department Visits Among Patients With Asthma and COPD

State University of New York at Buffalo1 site in 1 country6 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
albuterol
Conditions
Asthma
Sponsor
State University of New York at Buffalo
Enrollment
6
Locations
1
Primary Endpoint
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

The purpose of the proposed study is to determine whether the addition of inhaled corticosteroids to treatment with oral corticosteroids and albuterol would reduce repeat emergency department (ED) visits among patients treated for acute exacerbations of asthma and COPD discharged from the emergency department to home. The investigators hypothesize that patients treated with inhaled corticosteroids in addition to oral corticosteroids and albuterol will have lower rates of 30-day return visits to the emergency department than those patients treated with oral corticosteroids and albuterol only.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
September 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather Lindstrom

Research Assistant Professor

State University of New York at Buffalo

Eligibility Criteria

Inclusion Criteria

  • Treated in the ED at the Erie County Medical Center (ECMC) for acute symptoms of asthma or COPD during the study period
  • Patient age ≥ 18 years
  • Resident of the City of Buffalo or Erie County
  • Discharged to home
  • Patient expresses willingness to return to ECMC or own primary care provider for follow-up visits
  • Able to provide informed consent
  • Able to comprehend English language

Exclusion Criteria

  • Received oral or inhaled corticosteroids in the week before ED presentation
  • Presented to the ED primarily for prescription refills
  • Complicated comorbid conditions (e.g. renal disease, cardiovascular disease, CHF, HIV)
  • Admitted to ECMC or discharged to another facility
  • Previously enrolled during a prior visit to the ED during the study period
  • For female patients--pregnant or pregnancy status indeterminate
  • Antibiotics are prescribed to treat current asthma/COPD exacerbation.

Arms & Interventions

Standard of Care

Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED) Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

Intervention: albuterol

Standard of Care

Standard of Care: 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 4 days (1st dose will have been given in the ED) Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

Intervention: Prednisone

Treatment

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

Intervention: beclamethasone dipropionate

Treatment

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

Intervention: albuterol

Treatment

Treatment: 30 day QVAR® (beclamethasone dipropionate) inhaler (80 mcg, 1 puff twice daily) plus 30 day albuterol inhaler plus non-tapering course of oral prednisone (50 mg/d) for 5 days Spacers will be dispensed with all multiple dose inhalers (MDI) to promote proper use and administration of inhaled medications.

Intervention: Prednisone

Outcomes

Primary Outcomes

Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge

Time Frame: 30 days

Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.

Study Sites (1)

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