Asthma, COPD
Conditions
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.
Interventions
DRUGbeclamethasone dipropionate
Inhaler
DRUGalbuterol
Inhaler
DRUGPrednisone
Oral corticosteroid
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
albuterol: Inhaler
Prednisone: Oral corticosteroid | 3 |
| 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.
beclamethasone dipropionate: Inhaler
albuterol: Inhaler
Prednisone: Oral corticosteroid | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Treatment | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 57 years | 55 years | 56 years |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: 30 days
Population: Study was discontinued due to low enrollment. No 30 day return visit data was collected.