Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone propionate/salmeterol 250µg/50µg (FSC) (Drug); tiotropium bromide (TIO) (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Post-index Period COPD-related, Unadjusted CostsMean Number of COPD Exacerbations
Secondary outcome: Number of COPD-related Healthcare Encounters
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is age 40 or older
- Patient record indicates a new prescription claim for fluticasone
propionate/salmeterol (FSC) or tiotropium bromide (TIO) (first pharmacy claim defines
the index date)
- Patient records include at least two medical claims with a primary or non-primary
diagnosis of COPD (International Classification of Disease-9 [ICD-9] code 490. xx -
492. xx or 496. xx)
- At least one of the patient's ICD-9 codes for COPD is observed in the 12 months prior
to the first pharmacy claim for FSC or TIO (the index date)
Exclusion Criteria:
- A pharmacy claim for FSC or TIO prior to the index date
- The patient initiated FSC at a dose other than 250µg/50µg
- The patient initiated FSC and TIO at the same time
- The patient had one or more prescription with missing dosing information
- The patient had a prescription claim for the study medication other than the one they
started on at the index date within 60 days after the index date
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: November 23, 2011
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