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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAsthma
InterventionDrug: Fluticasone propionate
Drug: Budesonide
Drug: Montelukast
PhaseN/A
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT01328964
First ReceivedMarch 4, 2010
Last UpdatedSeptember 8, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateMarch 4, 2010
Last Updated DateSeptember 8, 2011
Start DateJune 2009
Estimated Primary Completion DateMay 2010
Current Primary Outcome MeasuresNumber of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years [Time Frame: January 1, 2000 to June 30, 2008] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period [Time Frame: 12 months prior to January 1, 2000 to June 30, 2008] [Designated as safety issue: No]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.
  • Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years [Time Frame: 12 months prior to January 1, 2000 to June 30, 2008] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
Official TitleComparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
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.
Detailed DescriptionNot Provided
Study TypeObservational
Study PhaseN/A
Study DesignObservational Model: Cohort, Time Perspective: Retrospective
ConditionAsthma
InterventionDrug: Fluticasone propionate
fluticasone propionate 44 mcg
Other Names:
Flovent® is a registered trademark of GlaxoSmithKlineDrug: Budesonide
budesonide
Other Names:
Singulair®is a registered trademark of Merck and CompanyDrug: Montelukast
montelukast
Other Names:
Rhinocort® is a registered trademark of AstraZeneca
Study Arm (s)Children Ages 4-11 with asthma
Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment9906
Estimated Completion DateMay 2010
Estimated Primary Completion DateMay 2010
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
GenderBoth
Ages4 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01328964
Other Study ID Numbers112608
Has Data Monitoring CommitteeNo
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateAugust 2011