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)
|ClinicalTrials.gov Identifier: NCT01331694|
Recruitment Status : Completed
First Posted : April 8, 2011
Results First Posted : April 8, 2011
Last Update Posted : July 2, 2017
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
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Drug: fluticasone/salmeterol combination (FSC) 250/50mcg Drug: tiotropium Drug: ipratropium bromide alone or in fixed dose combination with albuterol|
All population i.e. at least 40 years: Each initial maintenance treatment (IMT) cohort (FSC 250/50mcg dose only, IP, and TIO) includes patients aged 40 years and older with at least 9 months of continuous enrollment (6 months pre-index and at least three months post-index) with a primary or secondary diagnosis of COPD [International Classification of Disease, 9th revision, Clinical Modification (ICD-9-CM) codes 491.xx, 492.xx or 496.xx]. Patients are observed such that everyone provides minimum 6 months of pre index baseline data and minimum 3 months post index (risk analysis) and minimum 12 months post index for cost analysis. Patients must receive either a 30-day supply of FSC or IP or TIO as the initial IMT medication, indicating "intent to treat." Patients may not also have a prescription filled for the other IMT medication within 60 days of the index date, or for the combination therapy budesonide/ formoterol (BFC), an inhaled corticosteroid (ICS) or a long acting beta agonist (LABA). Six months of observation (continuous enrollment) prior to the index date is assessed to confirm that the patient meets the inclusion and exclusion criteria as well as to identify baseline characteristics and covariates. Cost analysis was done using a 12 months fixed follow up period. Outcome measures are assessed during the post-index period
Elderly cohort 65+: Identical methods and design were used for subanalyses in patients aged 65 years and over except comparison was FSC vs. TIO only.
75+ cohort: Identical methods and design were used for subanalyses in patients aged 75 years and over except comparison was FSC vs. TIO only.
|Study Type :||Observational|
|Actual Enrollment :||76130 participants|
|Official Title:||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)|
|Study Start Date :||July 2009|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
copd patients 65 years and older
Drug: fluticasone/salmeterol combination (FSC) 250/50mcg
patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg
Other Name: Advair (TM)Drug: tiotropium
patients initiating treatment with tiotropium
Other Name: Spiriva (TM)Drug: ipratropium bromide alone or in fixed dose combination with albuterol
patients initiating treatment with ipratropium/albuterol
- Time to First Chronic Obstructive Pulmonary Disease (COPD) Event [ Time Frame: Anytime from 30 days to 12 months after initial treatment arm prescription ]The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.
- Average Annual Adjusted Post-Index COPD-Related Costs [ Time Frame: Incurred over the 12 month period after initial treatment arm prescription ]Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331694
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|