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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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Asthma

Treatments

Drug: Budesonide
Drug: Fluticasone propionate
Drug: Montelukast

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

9,906 patients

Sex

All

Ages

4 to 11 years old

Volunteers

No Healthy Volunteers

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

Trial design

9,906 participants in 1 patient group

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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