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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03543176
• Collaborator: Optum-data vendor (Other)
• Enrollment: 789
• Location: 1
• Actual Duration (Months): 14.7
• Patients Per Site Per Month: 53.7

Study Details

Study Description

Brief Summary

The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Other: UMEC/VI; Other: FLUT/SAL; Other: CAT; Other: mMRC; Device: Ellipta; Device: Diskus

Study Design

• Study Type: Observational
• Actual Enrollment: 789 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
• Actual Study Start Date: May 31, 2018
• Actual Primary Completion Date: Aug 21, 2019
• Actual Study Completion Date: Aug 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
UMEC/VI The subjects in this arm had received, UMEC/VI as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual LAMA/LABA therapy, given via Ellipta .	Other: UMEC/VI; UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .; Other: CAT; Questionnaire used to asses Condition-related well-being, for COPD subjects.; Other: mMRC; Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.; Device: Ellipta; It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.
FLUT/SAL The subjects in this arm had received, FLUT/SAL as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy ICS/LABA treatment, given via DISKUS.	Other: FLUT/SAL; FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.; Other: CAT; Questionnaire used to asses Condition-related well-being, for COPD subjects.; Other: mMRC; Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.; Device: Diskus; It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire [Day 1]

   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.

2. Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale [Day 1]

   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).

Secondary Outcome Measures

1. Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics [12 months]

   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.

2. Mean Count of Unique Medications-Baseline All Cause Utilization [12 months]

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

3. Mean Total Number of Medications Dispensing-Baseline All Cause Utilization [12 months]

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

4. Percentage of Participants With All Cause Healthcare Resource Utilization [12 months]

   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.

5. Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts [12 months]

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

6. Length of Stay in Hospital-Baseline All Cause Utilization Counts [12 months]

   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.

7. Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts [12 months]

   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.

8. Mean Total Baseline All Cause Healthcare Costs [12 months]

   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.

9. Mean Count of Unique COPD Medications-Baseline COPD Medication [12 months]

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

10. Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications [12 months]

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

11. Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization [12 months]

    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.

12. Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts [12 months]

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

13. Length of Inpatient Stay-Baseline COPD Related Utilization Counts [12 months]

    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.

14. Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts [12 months]

    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.

15. Mean Total Baseline COPD-related Healthcare Costs [12 months]

    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.

16. Number of Participants With Atleast One Baseline COPD Exacerbation [12 months]

    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.

17. Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification [12 months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• =2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.

• Diagnosis codes J40-J44 will be included.

• =1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.

• Age >= 65 years.

• Self-reported health care provider diagnosis of COPD.

• Self-reported prescription for FLUT/SAL or UMEC/VI.

• 12 months of continuous enrollment during the Baseline period.

• Ability to complete the study survey in English.

Exclusion Criteria:

• =2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.

• Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.

• Claims for triple therapy (Inhaled Corticosteroid [ICS] + Long-acting Antimuscarinic [LAMA] + Long-acting Beta-agonist [LABA] during the Baseline period.

• Evidence of lung cancer diagnosis and/or treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Durham	North Carolina	United States	27709

Sponsors and Collaborators

• GlaxoSmithKline
• Optum-data vendor

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03543176
• Other Study ID Numbers: 208782
• First Posted: Jun 1, 2018
• Last Update Posted: Aug 5, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by GlaxoSmithKline: Cohort; Chronic obstructive pulmonary disease; Observational; GOLD; Claims; Health plan recruitment
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	A total of 789 claims linked analytic participants were enrolled in the study.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	392	397
COMPLETED	392	397
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	392	397	789
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	75.69 (6.01)	75.52 (6.10)	75.60 (6.05)
Sex: Female, Male (Count of Participants)
Female	201 51.3%	222 55.9%	423 53.6%
Male	191 48.7%	175 44.1%	366 46.4%
Race/Ethnicity, Customized (Count of Participants)
White, non-minority	357 91.1%	351 88.4%	708 89.7%
Black/Asian/Other Race, Minority	35 8.9%	44 11.1%	79 10%
Missing	0 0%	2 0.5%	2 0.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Low impact (0-9)	13.27 3.4%	11.34 2.9%
Medium impact (10-20)	51.28 13.1%	43.58 11%
High impact (21-30)	30.36 7.7%	35.01 8.8%
Very high impact, (31-40)	5.10 1.3%	10.08 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.448
	Comments	P-value for low impact of COPD is presented
	Method	Fisher Exact
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments	P-value for medium impact of COPD is presented
	Method	Fisher Exact
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.172
	Comments	P-value for high impact of COPD is presented
	Method	Fisher Exact
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments	P-value for very high impact of COPD is presented
	Method	Fisher Exact
	Comments

2. Primary Outcome

Title	Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
Description	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).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Grades (0-1)	51.79 13.2%	46.85 11.8%
Grades (2-4)	48.21 12.3%	53.15 13.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.176
	Comments	P-value for breathlessness reported in COPD assessed using mMRC is presented
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Scores on a scale]	2.53 (1.91)	2.49 (1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.732
	Comments	P-value for Baseline comorbidity burden score was calculated.
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Mean Count of Unique Medications-Baseline All Cause Utilization
Description	A count of unique medications filled in the 12-month Baseline period was calculated. The mean values has been presented.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Medications]	13.39 (5.99)	14.52 (6.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.013
	Comments	P-value for count of unique medications was calculated.
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
Description	A count of unique dispensing's for all medications filled in the 12-month Baseline period was calculated.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Medications dispensing]	43.55 (26.15)	46.22 (29.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.178
	Comments	P-value for total number of medications dispensing was calculated.
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Percentage of Participants With All Cause Healthcare Resource Utilization
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Inpatient stays	28.83 7.4%	31.49 7.9%
Emergency room visits	44.64 11.4%	50.38 12.7%
Ambulatory visits	100.00 25.5%	100.00 25.2%
Office visits	98.72 25.2%	97.98 24.7%
Outpatient visits	84.69 21.6%	87.41 22%

7. Secondary Outcome

Title	Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
Description	Mean number of inpatient admissions during the 12 months Baseline period has been presented.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Inpatient Hospital Admissions]	0.40 (0.76)	0.47 (0.85)

8. Secondary Outcome

Title	Length of Stay in Hospital-Baseline All Cause Utilization Counts
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Days]	3.51 (10.09)	3.95 (9.57)

9. Secondary Outcome

Title	Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Emergency room visits	0.91 (1.53)	1.18 (1.90)
Ambulatory visits	26.79 (18.10)	25.51 (17.76)
Office visits	16.70 (12.34)	15.54 (12.42)
Outpatient visits	10.12 (11.45)	10.04 (10.34)

10. Secondary Outcome

Title	Mean Total Baseline All Cause Healthcare Costs
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [US Dollars]	19915.66 (31213.46)	17591.88 (21533.79)

11. Secondary Outcome

Title	Mean Count of Unique COPD Medications-Baseline COPD Medication
Description	A count of unique COPD medications filled in the 12-month Baseline period was calculated. The mean values have been presented.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Medications]	0.99 (0.10)	0.99 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.692
	Comments	P-value for count of unique COPD medications was calculated
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
Description	A count of unique COPD dispensings for all medications filled in the 12-month Baseline period was calculated.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Medications dispensing]	2.50 (1.40)	1.76 (1.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umeclidinium/Vilanterol, Fluticasone /Salmeterol
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P-value for total number of COPD medications dispensing was calculated
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Inpatient stay	13.78 3.5%	13.60 3.4%
Emergency room visits	10.71 2.7%	16.37 4.1%
Ambulatory visits	83.93 21.4%	75.57 19%
Office visits	77.30 19.7%	61.46 15.5%
Outpatient visits	39.03 10%	28.97 7.3%

14. Secondary Outcome

Title	Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
Description	Mean number of Baseline COPD related inpatient admissions during the 12 months Baseline period has been presented.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Admissions]	0.17 (0.50)	0.17 (0.48)

15. Secondary Outcome

Title	Length of Inpatient Stay-Baseline COPD Related Utilization Counts
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [Days]	2.02 (8.34)	1.57 (6.18)

16. Secondary Outcome

Title	Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Emergency room visits	0.16 (0.55)	0.21 (0.54)
Ambulatory visits	3.21 (2.88)	2.38 (3.02)
Office visits	2.18 (2.21)	1.47 (1.72)
Outpatient visits	1.03 (1.78)	0.91 (2.25)

17. Secondary Outcome

Title	Mean Total Baseline COPD-related Healthcare Costs
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Mean (Standard Deviation) [US Dollars]	5008.86 (11551.58)	3797.44 (7246.79)

18. Secondary Outcome

Title	Number of Participants With Atleast One Baseline COPD Exacerbation
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
Count of Participants [Participants]	164 41.8%	184 46.3%

19. Secondary Outcome

Title	Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All enrolled Population.

Arm/Group Title	Umeclidinium/Vilanterol	Fluticasone /Salmeterol
Arm/Group Description	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	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.
Measure Participants	392	397
GOLD A with mMRC only	43.37 11.1%	37.28 9.4%
GOLD B with mMRC only	33.42 8.5%	38.54 9.7%
GOLD C with mMRC only	8.42 2.1%	9.57 2.4%
GOLD D with mMRC only	14.80 3.8%	14.61 3.7%
GOLD A with CAT only	11.73 3%	9.82 2.5%
GOLD B with CAT only	65.05 16.6%	65.99 16.6%
GOLD C with CAT only	1.53 0.4%	1.51 0.4%
GOLD D with CAT only	21.68 5.5%	22.67 5.7%
GOLD A with mMRC and CAT	10.20 2.6%	9.82 2.5%
GOLD B with mMRC or CAT	66.58 17%	65.99 16.6%
GOLD C with mMRC and CAT	1.02 0.3%	1.51 0.4%
GOLD D with mMRC or CAT	22.19 5.7%	22.67 5.7%

Adverse Events

Time Frame	Adverse events (AEs) were not collected as this is a cross-sectional retrospective claims study that utilized enrollment, medical, and pharmacy records from Optum's proprietary research claims database (ORD) without a GlaxoSmithKline drug of interest.
Adverse Event Reporting Description	AEs and serious adverse events (SAEs) were not collected.
Arm/Group Title	Umeclidinium/Vilanterol		Fluticasone /Salmeterol
Arm/Group Description	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		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.
All Cause Mortality
	Umeclidinium/Vilanterol		Fluticasone /Salmeterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Umeclidinium/Vilanterol		Fluticasone /Salmeterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Umeclidinium/Vilanterol		Fluticasone /Salmeterol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.