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The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children Ages 4-11 with asthma | Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate | Drug | fluticasone propionate 44 mcg |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study. | January 1, 2000 to June 30, 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant. |
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Inclusion Criteria:
Exclusion Criteria:
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Claims related to pediatric patients age 4-12 in the database with one or more outpatient pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or montelukast (MON) between January 1, 2000 and June 30, 2008.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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This was a retrospective observational study utilizing a large managed care database with linked pharmacy and medical claims. The dose of each inhaled corticosteroid was not known in the database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Propionate | Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma |
| FG001 | Budesonide | Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Budesonide | Drug | budesonide |
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| Montelukast | Drug | montelukast |
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| 12 months prior to January 1, 2000 to June 30, 2008 |
| Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study. | 12 months prior to January 1, 2000 to June 30, 2008 |
| FG002 | Montelukast | Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Propionate | Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma |
| BG001 | Budesonide | Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma |
| BG002 | Montelukast | Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study. | Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest. | Posted | Number | asthma events per 100 person years | January 1, 2000 to June 30, 2008 |
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| Secondary | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant. | Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest. | Posted | Mean | Standard Deviation | United States dollars | 12 months prior to January 1, 2000 to June 30, 2008 |
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| Secondary | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study. | Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest. | Posted | Number | Asthma related events per100 person year | 12 months prior to January 1, 2000 to June 30, 2008 |
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| Secondary | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant. | Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest. | Posted | Mean | Standard Deviation | United States dollars | 12 months prior to January 1, 2000 to June 30, 2008 |
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This was a retrospective observational study utilizing a large managed care database with linked pharmacy and medical claims. Serious adverse events and non-serious adverse events were not collected.
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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 | Fluticasone Propionate | Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma | 0 | 0 | 0 | 0 | ||
| EG001 | Budesonide | Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma | 0 | 0 | 0 | 0 | ||
| EG002 | Montelukast | Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma | 0 | 0 | 0 | 0 |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D019819 | Budesonide |
| D003132 | Commerce |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013676 | Technology, Industry, and Agriculture |
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