Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fluticasone propionate
* Drug: Budesonide
* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children Ages 4-11 with asthma<br>Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy | Drug: Fluticasone propionate<br>* fluticasone propionate 44 mcg<br>* Other names: Flovent® is a registered trademark of GlaxoSmithKline;Drug: Budesonide<br>* budesonide<br>* Other names: Singulair®is a registered trademark of Merck and Company;Drug: Montelukast<br>* montelukast<br>* Other names: Rhinocort® is a registered trademark of AstraZeneca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, asthma, outcomes, inhaled cortcosteroids