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临床试验/NCT01381458
NCT01381458已完成不适用

Differences in the Risk of Re-hospitalization and Other COPD-related (Chronic Obstructive Pulmonary Disease) Exacerbations and Costs for Patients Receiving Fluticasone Propionate-salmeterol Xinafoate Combination 250/50mcg (FSC) Versus Anticholinergics [i.e. Tiotropium (TIO) and Ipratropium or Combination Ipratropium-albuterol (IPR) Post-hospitalization or ED Visit for the Treatment of COPD.

GlaxoSmithKline0 个研究点目标入组 1,936 人开始时间: 2010年9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
1,936
主要终点
Risk of Hospitalization in COPD patients

研究概览

简要总结

This retrospective database study will assess differences in the risk of re-hospitalization and other COPD-related exacerbations and costs for patients receiving fluticasone propionate/salmeterol xinafoate combination 250/50 (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium - IPR)] post-hospitalization or Emergency Department (ED) visit for the treatment of COPD.

This is a hypotheses testing study. Associations are compared between FSC and AC cohorts.

Hypotheses for the primary outcome and key secondary outcomes are presented below:

Specifically the study hypotheses for the primary outcome being tested were:

Ho: There is no difference in risk of COPD-related hospitalization between FSC and AC Ha: There is a difference in risk of COPD-related hospitalization between FSC and AC

Hypothesis for the key secondary outcome of COPD-related costs that was tested was:

Ho: There is no difference in COPD-related costs between FSC and AC Ha: There is a difference in COPD-related costs between FSC and AC

详细描述

Managed care patients (aged >40 years) who were fluticasone propionate/salmeterol xinafoate combination (FSC)-naive in the 12 months pre-index period. The index-date was the date of discharge of the index Chronic Obstructive Pulmonary Disease (COPD)-related hospitalization/Emergency Department (ED) visit. Eligible patients were required to newly initiate or switch to drug therapy with FSC or ipratropium (IPR) / tiotropium (TIO) during the identification period (01/01/2004 to 01/31/2008) to treat COPD. Patients who switched to another maintenance medication or had an exacerbation in the treatment assessment period (30-days post-index date) were excluded from the study. Follow-up period was 12 months post treatment assessment period. Patients classified as being on FSC 250/50 versus anticholinergics (TIO, IP or IPR). Examined risk of COPD-related exacerbations such as hospitalizations, emergency department (ED) visits, COPD-related physician/outpatient visit with oral corticosteroid (OCS) or antibiotic prescription (ABX) within 5 days of physician/outpatient visit and COPD-related medical, pharmacy, and total healthcare costs in follow-up period.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥40 years of age at index discharge date
  • Continuous health plan eligibility in the pre-index, treatment assessment, and follow-up periods
  • Absence of other fluticasone propionate -salmeterol xinafoate doses or combination product of budesonide-formoterol anytime during pre-index, treatment assessment, and follow-up periods

排除标准

  • COPD-related exacerbation during the treatment assessment period
  • Any therapy change, which was defined as switching or augmenting index therapy during treatment assessment period
  • Absence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, and sarcoidosis) during the pre-index, treatment assessment, and follow-up periods

研究组 & 干预措施

COPD patients receiving pharmacotherapy

COPD patients age 40 years and older receiving pharmacotherapy to treat their COPD and an index event of COPD hospitalization or ER visit.

干预措施: FSC (Drug)

COPD patients receiving pharmacotherapy

COPD patients age 40 years and older receiving pharmacotherapy to treat their COPD and an index event of COPD hospitalization or ER visit.

干预措施: ACs (Drug)

结局指标

主要结局

Risk of Hospitalization in COPD patients

时间窗: January 1, 2003 through March 31, 2009 (up to 6 years)

Risk of hospitalization was assessed as any hospitalization that was catpured in the follow up period. We required this event to have a primary discharge dx of COPD (ICD-9 code 491.xx, 492.xx, 496.xx) thus assuring it to be COPD-related. a logistic regression model was run to examine this outcome.

次要结局

  • Number of COPD exacerbations(January 1, 2003 through March 31, 2009 (up to 6 years))
  • COPD-related Costs(January 1, 2003 through March 31, 2009 (up to 6 years))

研究者

申办方类型
Industry
责任方
Sponsor

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