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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Jacobi Medical Center | OTHER |
| Nassau University Medical Center | OTHER |
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To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.
This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Experimental | Budesonide, 2mg, 4 doses, plus standard care |
|
| P | Placebo Comparator | Placebo plus standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | 2mg/dose by nebulizer, four doses over 3 hours |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Percent Predicted | 4 hours post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Silverman, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nassau University Medical Center | East Meadow | New York | 11554 | United States | ||
| Long Island Jewish Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide | Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO |
| FG001 | Placob | Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide | Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | FEV1 Percent Predicted | Posted | Mean | Standard Deviation | percent predicted of FEV1 | 4 hours post-randomization |
|
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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 | Budesonide | Budesonide, 2mg, 4 doses, plus standard care Budesonide: 2mg/dose by nebulizer, four doses over 3 hours albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Silverman | North Shore Long Island Jewish Health System | 718-470-7501 | rsilverman@nshs.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000420 | Albuterol |
| D017265 | Procaterol |
| D009241 | Ipratropium |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| albuterol | Drug | 2.5mg/dose by nebulizer, 7 doses over 6 hours |
|
|
| Ipratropium bromide | Drug | 2.5 mg, one dose |
|
|
| Prednisone | Drug | 60mg PO |
|
|
| Queens |
| New York |
| 11042 |
| United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Forced expiratory volume at one second (FEV1) % predicted | Mean | Standard Deviation | percent predicted of FEV1 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Hospitalization | Posted | Number | percentage of participants | 6 hours |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Placebo | Placebo plus standard care albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours Ipratropium bromide: 2.5 mg, one dose Prednisone: 60mg PO | 0 | 49 | 0 | 49 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D006912 | Hydroxyquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |