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

Completed

Interventions: Drug: Fluticasone propionate
Drug: Budesonide
Drug: Montelukast

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Children Ages 4-11 with asthma	Fluticasone propionate	Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy
Children Ages 4-11 with asthma	Montelukast	Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy
Children Ages 4-11 with asthma	Budesonide	Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.