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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

NCT01328964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9906

Last updated 2017-07-06

Study results available
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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

Interventions

DRUG

Fluticasone propionate

fluticasone propionate 44 mcg

DRUG

Budesonide

budesonide

DRUG

Montelukast

montelukast

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328964 on ClinicalTrials.gov