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

NCT ID: NCT01328964

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9906 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Children Ages 4-11 with asthma

Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

Fluticasone propionate

Intervention Type: DRUG

fluticasone propionate 44 mcg

Budesonide

Intervention Type: DRUG

budesonide

Montelukast

Intervention Type: DRUG

montelukast

Interventions

Fluticasone propionate

fluticasone propionate 44 mcg

Intervention Type: DRUG

Budesonide

budesonide

Intervention Type: DRUG

Montelukast

montelukast

Intervention Type: DRUG

Other Intervention Names

Flovent® is a registered trademark of GlaxoSmithKline; Singulair®is a registered trademark of Merck and Company; Rhinocort® is a registered trademark of AstraZeneca

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112608

Identifier Type: -

Identifier Source: org_study_id