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. |
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Condition | Asthma |
Intervention | Drug: Fluticasone propionate Drug: Budesonide Drug: Montelukast |
Phase | N/A |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT01328964 |
First Received | March 4, 2010 |
Last Updated | September 8, 2011 |
Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | March 4, 2010 |
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Last Updated Date | September 8, 2011 |
Start Date | June 2009 |
Estimated Primary Completion Date | May 2010 |
Current Primary Outcome Measures | 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. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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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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 |
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 Description | Not Provided |
Study Type | Observational |
Study Phase | N/A |
Study Design | Observational Model: Cohort, Time Perspective: Retrospective |
Condition | Asthma |
Intervention | Drug: 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 Status | Completed |
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Estimated Enrollment | 9906 |
Estimated Completion Date | May 2010 |
Estimated Primary Completion Date | May 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 |
Gender | Both |
Ages | 4 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01328964 |
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Other Study ID Numbers | 112608 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | August 2011 |