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Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01331694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76130

Last updated 2017-07-02

Study results available
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Summary

To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP).

This is a hypothesis testing study

Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and FSC and IP

Hypothesis for the key secondary outcome of COPD-related costs that was tested was:

Ho: There is no difference in COPD-related costs between FSC and TIO and FSC and IP Ha: There is a difference in COPD-related costs between FSC and TIO and FSC and IP

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

fluticasone/salmeterol combination (FSC) 250/50mcg

patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg

DRUG

tiotropium

patients initiating treatment with tiotropium

DRUG

ipratropium bromide alone or in fixed dose combination with albuterol

patients initiating treatment with ipratropium/albuterol

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-05-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331694 on ClinicalTrials.gov