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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02499887
Other study ID # 754754
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date September 2016

Study information

Verified date June 2019
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
beclamethasone dipropionate
Inhaler
albuterol
Inhaler
Prednisone
Oral corticosteroid

Locations

Country Name City State
United States Erie County Medical Center Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge 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. 30 days
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