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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

fluticasone propionate 44 mcg

Other names: Flovent® is a registered trademark of GlaxoSmithKline

Budesonide

Drug

budesonide

Other names: Singulair®is a registered trademark of Merck and Company

Montelukast

Drug

montelukast

Other names: Rhinocort® is a registered trademark of AstraZeneca

Primary outcomes

Number 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

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 outcomes

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

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

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Apr 5, 2011
Registry last updated: Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed