Repeat Emergency Department Visits Among Patients With Asthma and COPD

NCT02499887 | Terminated Results

• 1 other identifier: 754754
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Drug: albuterol; Drug: Prednisone

Treatment

EXPERIMENTAL

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.

Drug: beclamethasone dipropionate; Drug: albuterol; Drug: Prednisone

Interventions

beclamethasone dipropionate DRUG

Inhaler

Also known as: Qvar

Treatment

albuterol DRUG

Inhaler

Also known as: Ventolin

Standard of Care; Treatment

Prednisone DRUG

Oral corticosteroid

Standard of Care; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone; Albuterol; Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnadienediols

Results Point of Contact

• Title: Heather Lindstrom
• Organization: UBMD Emergency Medicine

hlindstrom@ecmc.edu

716-898-4564

Study Officials

• Heather A Lindstrom, PhD

  University at Buffalo, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 16, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-06

Locations

US (1)