Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
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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.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: Fluticasone propionate Drug: Budesonide Drug: Montelukast |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population |
- 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 ] [ 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.
- 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.
| Enrollment: | 9906 |
| Study Start Date: | June 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Children Ages 4-11 with asthma
Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy
|
Drug: Fluticasone propionate
fluticasone propionate 44 mcg
Other Name: Flovent® is a registered trademark of GlaxoSmithKline
Drug: Budesonide
budesonide
Other Name: Singulair®is a registered trademark of Merck and Company
Drug: Montelukast
montelukast
Other Name: Rhinocort® is a registered trademark of AstraZeneca
|
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Claims related to pediatric patients age 4-12 in the database with one or more outpatient pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or montelukast (MON) between January 1, 2000 and June 30, 2008.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01328964 History of Changes |
| Other Study ID Numbers: | 112608 |
| Study First Received: | March 4, 2010 |
| Results First Received: | April 8, 2011 |
| Last Updated: | September 8, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
pediatric asthma outcomes inhaled cortcosteroids |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Fluticasone Montelukast Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents Leukotriene Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013