Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease

NCT ID: NCT01387178

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-02-28

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COPD patients - risk analysis population

Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. Patient records for the risk analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 3 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and June 30, 2008).

fluticasone propionate/salmeterol 250µg/50µg (FSC)

Intervention Type: DRUG

Patient records with evidence of COPD and prescription claims for FSC

tiotropium bromide (TIO)

Intervention Type: DRUG

Patient records with evidence of COPD and prescription claims for TIO

COPD patients - cost analysis population

Patient-records from patients aged 40 and older with at least 2 medical claims with a diagnosis of COPD, at least on diagnosis in the 12 months prior to the index date and at least one diagnosis in the post-index date observation period, and at least one prescription claim for either FSC 250 µg/50µg or TIO. The cost analysis population is a subset of the risk analysis population. Patient records for the cost analysis population will be required to have continuous medical and pharmacy health plan enrollment for at least 12 months before and at least 12 months after the index date. The index date will be defined as the date of the first prescription claim for FSC or TIO (between January 1, 2004 and September 30, 2007).

fluticasone propionate/salmeterol 250µg/50µg (FSC)

Intervention Type: DRUG

Patient records with evidence of COPD and prescription claims for FSC

tiotropium bromide (TIO)

Intervention Type: DRUG

Patient records with evidence of COPD and prescription claims for TIO

Interventions

fluticasone propionate/salmeterol 250µg/50µg (FSC)

Patient records with evidence of COPD and prescription claims for FSC

Intervention Type: DRUG

tiotropium bromide (TIO)

Patient records with evidence of COPD and prescription claims for TIO

Intervention Type: DRUG

Other Intervention Names

Advair®; Spriva®

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

111267

Identifier Type: -

Identifier Source: org_study_id