Clinical trial NCT01387178: Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Official title: Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: chronic obstructive pulmonary disease
cost and cost analysis
bronchodilators
healthcare utilization
fluticasone propionate/salmeterol
tiotropium
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-04
Enrollment: 22223
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient records for commercially-insured patients with chronic obstructive pulmonary disease (COPD) aged 40 and older. For the risk-analysis population, patients were required to have at least 12 months of continuous enrollment prior to the index date and at least 3 months of continuous enrollment after the index date. A subgroup analysis was conducted for costs that included patients in the total population who also had at least 12 months of continuous coverage following the index date (the cost-analysis population).

Brief 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.


Eligibility 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

Primary outcomes:
measure: Post-index Period COPD-related, Unadjusted Costs
timeFrame: 1 year
measure: Mean Number of COPD Exacerbations
timeFrame: 1 year
Secondary outcomes:
measure: Number of COPD-related Healthcare Encounters
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: