Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation
caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in
COPD appears to be irreversible, evidence suggests that the course of COPD can be altered
through measures such as smoking cessation, pulmonary rehabilitation, and the use of
pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to
reduce the incidence of acute exacerbations and the associated hospitalizations and
emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be
accomplished with the long-acting anticholinergic tiotropium (TIO), long acting
beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or
combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g.
fluticasone propionate/salmeterol [FSC]).
The objective of this study is to compare the benefits of combination long-acting
beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The
study compares the risk of COPD exacerbations and COPD-related healthcare utilization and
costs for commercially-insured patients age 40 and older who were prescribed FSC to those
prescribed TIO. The null hypothesis is that no difference exists between the costs and
outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis
is that patients treated with either TIO or FSC will incur lower costs and use fewer
healthcare resources for the management of COPD.
The source of data for this study was the Ingenix Impact database (formerly the Integrated
Healthcare Information Services [IHCIS] database). This is an administrative claims database
that includes patient-level data on enrollment, facility, professional, and pharmacy
services from approximately 50 million patients covered by more than 40 managed care health
plans across the United States (US).
The study design is a retrospective cohort study.
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