Repeat Emergency Department Visits Among Patients With Asthma and COPD

NCT ID: NCT02499887

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

albuterol

Intervention Type: DRUG

Inhaler

Prednisone

Intervention Type: DRUG

Oral corticosteroid

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.

Group Type: EXPERIMENTAL

beclamethasone dipropionate

Intervention Type: DRUG

Inhaler

albuterol

Intervention Type: DRUG

Inhaler

Prednisone

Intervention Type: DRUG

Oral corticosteroid

Interventions

beclamethasone dipropionate

Inhaler

Intervention Type: DRUG

albuterol

Inhaler

Intervention Type: DRUG

Prednisone

Oral corticosteroid

Intervention Type: DRUG

Other Intervention Names

Qvar; Ventolin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Heather Lindstrom

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather A Lindstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo, Department of Emergency Medicine

Locations

Erie County Medical Center

Buffalo, New York, United States

Countries

United States

Other Identifiers

754754

Identifier Type: -

Identifier Source: org_study_id