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

NCT01387178 | Completed Results

• 1 other identifier: 111267
• Study Type: observational
• Target: 22,223
• Locations: 0 countries
• Sites: N/A

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

Keywords

chronic obstructive pulmonary disease; cost and cost analysis; bronchodilators; healthcare utilization; fluticasone propionate/salmeterol; tiotropium

Outcome Measures

Primary Outcomes (2)

• Post-index Period COPD-related, Unadjusted Costs

  The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg \[FSC\] or tiotropium bromide \[TIO\]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.

  1 year

• Mean Number of COPD Exacerbations

  Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.

  1 year

Secondary Outcomes (1)

• Number of COPD-related Healthcare Encounters

  1 year

Study Arms (2)

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).

Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC); Drug: tiotropium bromide (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).

Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC); Drug: tiotropium bromide (TIO)

Interventions

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

Patient records with evidence of COPD and prescription claims for FSC

Also known as: Advair®

COPD patients - cost analysis population; COPD patients - risk analysis population

tiotropium bromide (TIO) DRUG

Patient records with evidence of COPD and prescription claims for TIO

Also known as: Spriva®

COPD patients - cost analysis population; COPD patients - risk analysis population

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: July 4, 2011
• Study Start: July 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: May 17, 2017
• Results First Posted: October 28, 2011

Record last verified: 2017-05