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临床试验/NCT01328964
NCT01328964已完成不适用

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

GlaxoSmithKline0 个研究点目标入组 9,906 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
9,906
主要终点
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • diagnosis of Cystic Fibrosis
  • ≥ 1 Rx claim for any asthma controller in the pre-index period

研究组 & 干预措施

Children Ages 4-11 with asthma

Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

干预措施: Fluticasone propionate (Drug)

Children Ages 4-11 with asthma

Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

干预措施: Budesonide (Drug)

Children Ages 4-11 with asthma

Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy

干预措施: Montelukast (Drug)

结局指标

主要结局

Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years

时间窗: 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.

次要结局

  • Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years(12 months prior to January 1, 2000 to June 30, 2008)
  • Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period(12 months prior to January 1, 2000 to June 30, 2008)

研究者

申办方类型
Industry
责任方
Sponsor

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