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Exclusion criteria prevented enrollment of adequate # of participants
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beclamethasone dipropionate | Drug | Inhaler |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather A Lindstrom, PhD | University at Buffalo, Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at presentation to emergency department |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was discontinued due to low enrollment. No 30 day return visit data was collected. | Posted | 30 days |
|
Enrolled patients were contacted within 72 hours of ED discharge. Subjects were asked to describe how they were taking study medications and whether or not they were experiencing any side effects of the medication.
Adverse event description does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Lindstrom | UBMD Emergency Medicine | 716-898-4564 | hlindstrom@ecmc.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000420 | Albuterol |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| albuterol | Drug | Inhaler |
|
|
| Prednisone | Drug | Oral corticosteroid |
|
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
Information on age of all subjects
| Count of Participants |
| Participants |
|
| Age, Continuous | Age at presentation to emergency department | Information on age of all subjects | Median | Full Range | years |
|
| Sex: Female, Male | Sex of all enrolled subjects | Sex of all enrolled subjects | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 3 | 0 | 3 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011244 | Pregnadienediols |