Asthma
Conditions
Keywords
pediatric, asthma, outcomes, inhaled cortcosteroids
Brief summary
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.
Interventions
DRUGFluticasone propionate
fluticasone propionate 44 mcg
DRUGBudesonide
budesonide
DRUGMontelukast
montelukast
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* ICD-9 code for asthma * one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between January 1, 2000 and June 30, 2008 * ages 4 to 11 years
Exclusion criteria
* diagnosis of Cystic Fibrosis * ≥ 1 Rx claim for any asthma controller in the pre-index period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | January 1, 2000 to June 30, 2008 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | 12 months prior to January 1, 2000 to June 30, 2008 | 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. |
| Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | 12 months prior to January 1, 2000 to June 30, 2008 | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Propionate Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma | 2,212 |
| Budesonide Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma | 3,270 |
| Montelukast Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma | 4,424 |
| Total | 9,906 |
Baseline characteristics
| Characteristic | Fluticasone Propionate | Budesonide | Montelukast | Total |
|---|---|---|---|---|
| Age, Continuous | 7.18 Years STANDARD_DEVIATION 2.2 | 7.30 Years STANDARD_DEVIATION 2.27 | 7.21 Years STANDARD_DEVIATION 2.23 | 7.23 Years STANDARD_DEVIATION 2.23 |
| Sex: Female, Male Female | 897 Participants | 1267 Participants | 1797 Participants | 3961 Participants |
| Sex: Female, Male Male | 1315 Participants | 2003 Participants | 2627 Participants | 5945 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: January 1, 2000 to June 30, 2008
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations | 0.89 asthma events per 100 person years |
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Emergency Department Visits | 3.35 asthma events per 100 person years |
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations or Emergency Department Visits | 4.17 asthma events per 100 person years |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations | 0.61 asthma events per 100 person years |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Emergency Department Visits | 5.30 asthma events per 100 person years |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations or Emergency Department Visits | 5.85 asthma events per 100 person years |
p-value: <0.000195% CI: [0.51, 0.974]Regression, Cox
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.
Time frame: 12 months prior to January 1, 2000 to June 30, 2008
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Medical Costs | 25 United States dollars | Standard Deviation 126 |
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Pharmacy Costs | 20 United States dollars | Standard Deviation 40 |
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Total Costs | 45 United States dollars | Standard Deviation 136 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Total Costs | 59 United States dollars | Standard Deviation 186 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Medical Costs | 27 United States dollars | Standard Deviation 166 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Pharmacy Costs | 32 United States dollars | Standard Deviation 71 |
p-value: <0.00195% CI: [-19, -9]Regression, Linear
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.
Time frame: 12 months prior to January 1, 2000 to June 30, 2008
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Medical Costs | 26 United States dollars | Standard Deviation 165 |
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Pharmacy Costs | 21 United States dollars | Standard Deviation 87 |
| Fluticasone Propionate | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Total Costs | 48 United States dollars | Standard Deviation 190 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Medical Costs | 27 United States dollars | Standard Deviation 176 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Pharmacy Costs | 48 United States dollars | Standard Deviation 75 |
| Budesonide | Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period | Monthly Total Costs | 75 United States dollars | Standard Deviation 197 |
p-value: <0.000195% CI: [-28, -27]Regression, Linear
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.
Time frame: 12 months prior to January 1, 2000 to June 30, 2008
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations | 0.71 Asthma related events per100 person year |
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Emergency Department Visits | 3.40 Asthma related events per100 person year |
| Fluticasone Propionate | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations or Emergency Department Visits | 4.07 Asthma related events per100 person year |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations | 0.62 Asthma related events per100 person year |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Emergency Department Visits | 4.76 Asthma related events per100 person year |
| Budesonide | Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years | Hospitalizations or Emergency Department Visits | 5.29 Asthma related events per100 person year |
p-value: 0.049595% CI: [0.565, 0.999]Regression, Cox