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Repeat Emergency Department Visits Among Patients With Asthma and COPD

Not Applicable
Terminated
Conditions
Asthma
COPD
Interventions
Drug: beclamethasone dipropionate
Registration Number
NCT02499887
Lead Sponsor
State University of New York at Buffalo
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
6
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatmentbeclamethasone dipropionateTreatment: 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.
Standard of CarealbuterolStandard 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.
Standard of CarePrednisoneStandard 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.
TreatmentPrednisoneTreatment: 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.
TreatmentalbuterolTreatment: 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.
Primary Outcome Measures
NameTimeMethod
Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge30 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Erie County Medical Center

🇺🇸

Buffalo, New York, United States

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