Trial Outcomes & Findings for Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness (NCT NCT03543176)

NCT ID: NCT03543176

Last Updated: 2020-08-05

Results Overview

The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims \>= 1.

• Recruitment status: COMPLETED
• Target enrollment: 789 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2020-08-05

Participant Flow

This cross-sectional observational survey study aimed to assess symptom burden and Baseline clinical and economic characteristics in chronic obstructive pulmonary disease (COPD) participants treated with single-inhaler dual therapies in adult Medicare Advantage (MA) enrollees with COPD diagnosis and treatment.

A total of 789 claims linked analytic participants were enrolled in the study.

Participant milestones

Measure	Umeclidinium/Vilanterol Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Overall Study STARTED	392	397
Overall Study COMPLETED	392	397
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness

Baseline characteristics by cohort

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.	Total n=789 Participants Total of all reporting groups
Age, Continuous	75.69 Years STANDARD_DEVIATION 6.01 • n=5 Participants	75.52 Years STANDARD_DEVIATION 6.10 • n=7 Participants	75.60 Years STANDARD_DEVIATION 6.05 • n=5 Participants
Sex: Female, Male Female	201 Participants n=5 Participants	222 Participants n=7 Participants	423 Participants n=5 Participants
Sex: Female, Male Male	191 Participants n=5 Participants	175 Participants n=7 Participants	366 Participants n=5 Participants
Race/Ethnicity, Customized White, non-minority	357 Participants n=5 Participants	351 Participants n=7 Participants	708 Participants n=5 Participants
Race/Ethnicity, Customized Black/Asian/Other Race, Minority	35 Participants n=5 Participants	44 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled Population.

The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims >= 1.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire Low impact (0-9)	13.27 Percentage of participants	11.34 Percentage of participants
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire Medium impact (10-20)	51.28 Percentage of participants	43.58 Percentage of participants
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire High impact (21-30)	30.36 Percentage of participants	35.01 Percentage of participants
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire Very high impact, (31-40)	5.10 Percentage of participants	10.08 Percentage of participants

PRIMARY outcome

Timeframe: Day 1

Population: All enrolled Population.

Breathlessness was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The score (Grade) was the number that best fit the participant's level of activity. The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale Grades (0-1)	51.79 Percentage of participants	46.85 Percentage of participants
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale Grades (2-4)	48.21 Percentage of participants	53.15 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

A comorbidity score was calculated based on the presence of diagnosis codes on medical claims in the Baseline period. The mean score has been presented. the scores was categorized into the following groups: one to two, three to four and five or more.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics	2.53 Scores on a scale Standard Deviation 1.91	2.49 Scores on a scale Standard Deviation 1.74

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

A count of unique medications filled in the 12-month Baseline period was calculated. The mean values has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Count of Unique Medications-Baseline All Cause Utilization	13.39 Medications Standard Deviation 5.99	14.52 Medications Standard Deviation 6.67

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

A count of unique dispensing's for all medications filled in the 12-month Baseline period was calculated.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Total Number of Medications Dispensing-Baseline All Cause Utilization	43.55 Medications dispensing Standard Deviation 26.15	46.22 Medications dispensing Standard Deviation 29.46

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits, emergency department (ED) visits, and inpatient stays were calculated in the 12-month Baseline period. Percentage of participants with inpatient stays, emergency room visits, ambulatory visits, office visits and outpatient visits in Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Percentage of Participants With All Cause Healthcare Resource Utilization Inpatient stays	28.83 Percentage of participants	31.49 Percentage of participants
Percentage of Participants With All Cause Healthcare Resource Utilization Emergency room visits	44.64 Percentage of participants	50.38 Percentage of participants
Percentage of Participants With All Cause Healthcare Resource Utilization Ambulatory visits	100.00 Percentage of participants	100.00 Percentage of participants
Percentage of Participants With All Cause Healthcare Resource Utilization Office visits	98.72 Percentage of participants	97.98 Percentage of participants
Percentage of Participants With All Cause Healthcare Resource Utilization Outpatient visits	84.69 Percentage of participants	87.41 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Mean number of inpatient admissions during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts	0.40 Inpatient Hospital Admissions Standard Deviation 0.76	0.47 Inpatient Hospital Admissions Standard Deviation 0.85

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of inpatient stays were calculated in the 12-month Baseline period. Length of stay during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Length of Stay in Hospital-Baseline All Cause Utilization Counts	3.51 Days Standard Deviation 10.09	3.95 Days Standard Deviation 9.57

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits and ED visits were calculated in the 12-month Baseline period. Mean number of emergency room, ambulatory, office and outpatient visits during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts Emergency room visits	0.91 Hospital visits Standard Deviation 1.53	1.18 Hospital visits Standard Deviation 1.90
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts Ambulatory visits	26.79 Hospital visits Standard Deviation 18.10	25.51 Hospital visits Standard Deviation 17.76
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts Office visits	16.70 Hospital visits Standard Deviation 12.34	15.54 Hospital visits Standard Deviation 12.42
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts Outpatient visits	10.12 Hospital visits Standard Deviation 11.45	10.04 Hospital visits Standard Deviation 10.34

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Consumer Price Index-adjusted costs were assessed for the 12-month Baseline period. Costs were calculated as total costs, pharmacy costs, and medical costs; medical costs include ambulatory (physician office and hospital outpatient) costs, emergency costs, inpatient costs, and other costs. Mean total all cause healthcare costs that includes medical costs and pharmacy costs during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Total Baseline All Cause Healthcare Costs	19915.66 US Dollars Standard Deviation 31213.46	17591.88 US Dollars Standard Deviation 21533.79

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

A count of unique COPD medications filled in the 12-month Baseline period was calculated. The mean values have been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Count of Unique COPD Medications-Baseline COPD Medication	0.99 Medications Standard Deviation 0.10	0.99 Medications Standard Deviation 0.09

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

A count of unique COPD dispensings for all medications filled in the 12-month Baseline period was calculated.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications	2.50 Medications dispensing Standard Deviation 1.40	1.76 Medications dispensing Standard Deviation 1.11

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits, ED visits, and inpatient stays were calculated in the 12-month Baseline period. Utilization defined was considered COPD-related when a diagnosis code for COPD is in the primary position. Percentage of participants with inpatient stay, emergency room, ambulatory, office and outpatient visits during the 12-months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization Inpatient stay	13.78 Percentage of participants	13.60 Percentage of participants
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization Emergency room visits	10.71 Percentage of participants	16.37 Percentage of participants
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization Ambulatory visits	83.93 Percentage of participants	75.57 Percentage of participants
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization Office visits	77.30 Percentage of participants	61.46 Percentage of participants
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization Outpatient visits	39.03 Percentage of participants	28.97 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Mean number of Baseline COPD related inpatient admissions during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts	0.17 Admissions Standard Deviation 0.50	0.17 Admissions Standard Deviation 0.48

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of inpatient stays were calculated in the 12-month Baseline period. Baseline COPD related length of inpatient stay during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Length of Inpatient Stay-Baseline COPD Related Utilization Counts	2.02 Days Standard Deviation 8.34	1.57 Days Standard Deviation 6.18

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Binary indicators and counts of ambulatory (physician office and hospital outpatient) visits and ED visits were calculated in the 12-month Baseline period. Mean number of Baseline COPD related emergency room, ambulatory, office and outpatient visits during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts Emergency room visits	0.16 Hospital visits Standard Deviation 0.55	0.21 Hospital visits Standard Deviation 0.54
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts Ambulatory visits	3.21 Hospital visits Standard Deviation 2.88	2.38 Hospital visits Standard Deviation 3.02
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts Office visits	2.18 Hospital visits Standard Deviation 2.21	1.47 Hospital visits Standard Deviation 1.72
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts Outpatient visits	1.03 Hospital visits Standard Deviation 1.78	0.91 Hospital visits Standard Deviation 2.25

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Consumer Price Index-adjusted costs were assessed for the 12-month Baseline period. Costs was calculated as total costs, pharmacy costs, and medical costs; medical costs include ambulatory (physician office and hospital outpatient) costs, emergency costs, inpatient costs, and other costs. Costs defined was considered COPD-related if the claim has a diagnosis code for COPD in the primary position or is for a medication used to treat COPD. Mean total Baseline COPD related healthcare costs that includes medical costs and pharmacy costs during the 12 months Baseline period has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Mean Total Baseline COPD-related Healthcare Costs	5008.86 US Dollars Standard Deviation 11551.58	3797.44 US Dollars Standard Deviation 7246.79

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

Whether the participant has evidence of a COPD exacerbation during the 12-month Baseline period was captured. A moderate COPD exacerbation was defined as either an emergency room visit with the primary diagnosis of COPD and/or an ambulatory visit with the primary diagnosis of COPD. The COPD-related qualifying emergency room or ambulatory event must also have a dispensing of antibiotics or systemic corticosteroids +/- 5 days from the date of service of the emergency room or ambulatory event. A severe COPD exacerbation was defined as a hospitalization with a primary diagnosis code of COPD. The count of participants with atleast one COPD exacerbation has been presented.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Number of Participants With Atleast One Baseline COPD Exacerbation	164 Participants	184 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled Population.

The GOLD categories were classified based on CAT and mMRC scores. GOLD A includes participants reporting COPD CAT symptoms score <10 and mMRC as 0-1; GOLD B includes participants reporting CAT symptom score >=10 and mMRC as >=2; GOLD C includes participants reporting exacerbation history as >=2 or >=1 leading to hospitalization; GOLD D includes participants reporting exacerbation history as 0 or 1 and not leading to hospitalization. The number of participants in each GOLD category of symptom burden and exacerbation, was presented. The calculation used was count of COPD exacerbations during the Baseline combined with CAT total score and mMRC score to create mutually exclusive counts for each category.

Outcome measures

Measure	Umeclidinium/Vilanterol n=392 Participants Participants in this arm received Umeclidinium/Vilanterol as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual Long-acting anti-muscarinic (LAMA)/ Long-acting beta-agonist (LABA) therapy, given via Ellipta	Fluticasone /Salmeterol n=397 Participants Participants in this arm received Fluticasone/Salmeterol as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy Inhaled Corticosteroid (ICS)/LABA treatment, given via DISKUS.
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD A with mMRC only	43.37 Percentage of participants	37.28 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD B with mMRC only	33.42 Percentage of participants	38.54 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD C with mMRC only	8.42 Percentage of participants	9.57 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD D with mMRC only	14.80 Percentage of participants	14.61 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD A with CAT only	11.73 Percentage of participants	9.82 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD B with CAT only	65.05 Percentage of participants	65.99 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD C with CAT only	1.53 Percentage of participants	1.51 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD D with CAT only	21.68 Percentage of participants	22.67 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD A with mMRC and CAT	10.20 Percentage of participants	9.82 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD B with mMRC or CAT	66.58 Percentage of participants	65.99 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD C with mMRC and CAT	1.02 Percentage of participants	1.51 Percentage of participants
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification GOLD D with mMRC or CAT	22.19 Percentage of participants	22.67 Percentage of participants

Adverse Events

Umeclidinium/Vilanterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluticasone /Salmeterol

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

Email: GSKClinicalSupportHD@gsk.com

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