Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population (NCT NCT01337336)

Results Overview

The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

Recruitment status

COMPLETED

Target enrollment

1 participants

Primary outcome timeframe

Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	FSC Cohort Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Overall Study STARTED	1078	2923
Overall Study COMPLETED	1078	2923
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FSC Cohort n=1078 Participants Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort n=2923 Participants Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.	Total n=4001 Participants Total of all reporting groups
Age, Continuous	57.8 Years STANDARD_DEVIATION 9.8 • n=5 Participants	60.3 Years STANDARD_DEVIATION 10.3 • n=7 Participants	59.6 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	742 Participants n=5 Participants	1910 Participants n=7 Participants	2652 Participants n=5 Participants
Sex: Female, Male Male	336 Participants n=5 Participants	1013 Participants n=7 Participants	1349 Participants n=5 Participants

PRIMARY outcome

Timeframe: Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)

Population: Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).

The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

Outcome measures

Outcome measures
Measure	FSC Cohort n=1078 Participants Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort n=2923 Participants Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation	200 participants	674 participants

SECONDARY outcome

Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

Population: Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).

The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

Outcome measures

Outcome measures
Measure	FSC Cohort n=1078 Participants Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort n=2923 Participants Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Number of Participants With the Indicated COPD-related Exacerbations COPD-related hospitalization	35 participants	168 participants
Number of Participants With the Indicated COPD-related Exacerbations COPD-related ER visit	37 participants	171 participants
Number of Participants With the Indicated COPD-related Exacerbations COPD-related physician + Rx visit	156 participants	448 participants
Number of Participants With the Indicated COPD-related Exacerbations COPD-related hospitalization/ER visit	63 participants	307 participants

SECONDARY outcome

Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

Population: Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).

Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

Outcome measures

Outcome measures
Measure	FSC Cohort n=1078 Participants Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort n=2923 Participants Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Mean Annual COPD-related Costs Per Participant COPD-related medical costs	670 United States (US) dollars Standard Deviation 2923	1003 United States (US) dollars Standard Deviation 4095
Mean Annual COPD-related Costs Per Participant COPD-related pharmacy costs	934 United States (US) dollars Standard Deviation 814	684 United States (US) dollars Standard Deviation 724
Mean Annual COPD-related Costs Per Participant COPD-related total costs	1604 United States (US) dollars Standard Deviation 3187	1687 United States (US) dollars Standard Deviation 4299

SECONDARY outcome

Timeframe: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)

Population: Managed care enrollees (aged \>=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).

The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.

Outcome measures

Outcome measures
Measure	FSC Cohort n=1078 Participants Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day	AC Cohort n=2923 Participants Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Number of the Indicated COPD-related Exacerbations COPD-related ER visit	0.06 number of exacerbations Standard Deviation 0.4	0.07 number of exacerbations Standard Deviation 0.4
Number of the Indicated COPD-related Exacerbations COPD-related hospitalization	0.04 number of exacerbations Standard Deviation 0.2	0.07 number of exacerbations Standard Deviation 0.3
Number of the Indicated COPD-related Exacerbations COPD-related physician (phy)+Rx visit	0.19 number of exacerbations Standard Deviation 0.6	0.20 number of exacerbations Standard Deviation 0.6
Number of the Indicated COPD-related Exacerbations COPD-related hospitalization/ER visit	0.09 number of exacerbations Standard Deviation 0.5	0.14 number of exacerbations Standard Deviation 0.5
Number of the Indicated COPD-related Exacerbations COPD-related hospitalization/ER visit/phy+Rx visit	0.29 number of exacerbations Standard Deviation 0.8	0.34 number of exacerbations Standard Deviation 0.8

Adverse Events

FSC Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AC Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER