Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RC - 3425 | Other Identifier | Institutional/Allegheny Singer Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Budesonide | Active Comparator | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks |
|
| Usual care | Active Comparator | Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulized Budesonide | Drug | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wheezing/Asthma/Bronchospasm Relapse Rate | This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Cortisol Levels | This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care). | 3 weeks |
| Forced Expiratory Volume in 1 Second (FEV1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Skoner, MD | West Penn Allegheny Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Pediatric Associates | Bellevue | Pennsylvania | 15202 | United States | ||
| Allegheny General Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Budesonide | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks |
| FG001 | Usual Care | Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid. Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
61 subjects were enrolled and 31 were randomized to nebulized budesonide and 30 to standard of care. 74% of subjects enrolled in the nebulized budesonide and 83% enrolled in the standard care group completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Budesonide | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks |
| BG001 | Usual Care |
| 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 | Wheezing/Asthma/Bronchospasm Relapse Rate | This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period. | Posted | Number | percentage of cases of asthma relapse | 3 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Budesonide | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Skoner, MD | Allegheny Singer Research Institute, WPAHS | 412-359-4099 | dskoner@hsc.wvu.edu |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care (albuterol with or without oral steroid) | Drug | Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid) |
|
This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
| 3 weeks |
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Urinary Cortisol Levels | This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care). | Posted | Mean | Standard Deviation | ng cortisol/mg creatinine | 3 weeks |
|
|
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) | This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care. | Posted | Mean | Standard Deviation | % Predicted | 3 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Usual Care | Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid. Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid) | 0 | 30 | 0 | 30 |
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |