Trial Outcomes & Findings for 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) (NCT NCT01331694)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

76130 participants

Primary outcome timeframe

Anytime from 30 days to 12 months after initial treatment arm prescription

Results posted on

2017-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Risk Population: FSC Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg	Risk Population: IP Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)	Risk Population: TIO Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg	Cost Population: FSC Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg	Cost Population: IP Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)	Cost Population: TIO Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
Overall Study STARTED	16684	14449	12659	12595	10617	9126
Overall Study COMPLETED	16684	14449	12659	12595	10617	9126
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risk Population: FSC n=16684 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg	Risk Population: IP n=14449 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)	Risk Population: TIO n=12659 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg	Cost Population: FSC n=12595 Participants Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg	Cost Population: IP n=10617 Participants Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)	Cost Population: TIO n=9126 Participants Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg	Total n=76130 Participants Total of all reporting groups
Age, Continuous	62.8 Years STANDARD_DEVIATION 12.00 • n=5 Participants	65.2 Years STANDARD_DEVIATION 12.59 • n=7 Participants	64.5 Years STANDARD_DEVIATION 11.33 • n=5 Participants	62.8 Years STANDARD_DEVIATION 11.92 • n=4 Participants	65.0 Years STANDARD_DEVIATION 12.42 • n=21 Participants	64.5 Years STANDARD_DEVIATION 11.34 • n=8 Participants	64.0 Years STANDARD_DEVIATION 12.06 • n=8 Participants
Sex: Female, Male Female	9127 Participants n=5 Participants	7143 Participants n=7 Participants	5862 Participants n=5 Participants	6914 Participants n=4 Participants	5298 Participants n=21 Participants	4256 Participants n=8 Participants	38600 Participants n=8 Participants
Sex: Female, Male Male	7557 Participants n=5 Participants	7306 Participants n=7 Participants	6797 Participants n=5 Participants	5681 Participants n=4 Participants	5319 Participants n=21 Participants	4870 Participants n=8 Participants	37530 Participants n=8 Participants

PRIMARY outcome

Timeframe: Anytime from 30 days to 12 months after initial treatment arm prescription

Population: All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.

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.

Outcome measures

Outcome measures
Measure	Risk Population: FSC n=16684 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg	Risk Population: IP n=14449 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)	Risk Population TIO n=12659 Participants Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
Time to First Chronic Obstructive Pulmonary Disease (COPD) Event Hospitalization or emergency department visit	325.17 days Standard Error 0.39	315.89 days Standard Error 0.56	321.59 days Standard Error 0.51
Time to First Chronic Obstructive Pulmonary Disease (COPD) Event Emergency department visit	330.24 days Standard Error 0.28	324.47 days Standard Error 0.43	328.48 days Standard Error 0.37
Time to First Chronic Obstructive Pulmonary Disease (COPD) Event Outpatient visit with oral steroid fill	332.74 days Standard Error 0.22	328.23 days Standard Error 0.31	331.23 days Standard Error 0.30
Time to First Chronic Obstructive Pulmonary Disease (COPD) Event Outpatient visit with antibiotic fill	329.96 days Standard Error 0.30	326.73 days Standard Error 0.39	326.70 days Standard Error 0.39

SECONDARY outcome

Timeframe: Incurred over the 12 month period after initial treatment arm prescription

Population: All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States

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.