Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Cohort, Chronic obstructive pulmonary disease, Observational, GOLD, Claims, Health plan recruitment
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.
Interventions
OTHERUMEC/VI
UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .
OTHERFLUT/SAL
FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.
OTHERCAT
Questionnaire used to asses Condition-related well-being, for COPD subjects.
OTHERmMRC
Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.
DEVICEEllipta
It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.
DEVICEDiskus
It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.
Sponsors
UnitedHealth Group
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
A total of 789 claims linked analytic participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 392 |
| 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. | 397 |
| Total | 789 |
Baseline characteristics
| Characteristic | Fluticasone /Salmeterol | Total | Umeclidinium/Vilanterol |
|---|---|---|---|
| Age, Continuous | 75.52 Years STANDARD_DEVIATION 6.1 | 75.60 Years STANDARD_DEVIATION 6.05 | 75.69 Years STANDARD_DEVIATION 6.01 |
| Race/Ethnicity, Customized Black/Asian/Other Race, Minority | 44 Participants | 79 Participants | 35 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White, non-minority | 351 Participants | 708 Participants | 357 Participants |
| Sex: Female, Male Female | 222 Participants | 423 Participants | 201 Participants |
| Sex: Female, Male Male | 175 Participants | 366 Participants | 191 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umeclidinium/Vilanterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | Low impact (0-9) | 13.27 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | Medium impact (10-20) | 51.28 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | High impact (21-30) | 30.36 Percentage of participants |
| Umeclidinium/Vilanterol | 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 |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | Very high impact, (31-40) | 10.08 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | Low impact (0-9) | 11.34 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | High impact (21-30) | 35.01 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire | Medium impact (10-20) | 43.58 Percentage of participants |
p-value: 0.448Fisher Exact
p-value: 0.033Fisher Exact
p-value: 0.172Fisher Exact
p-value: 0.01Fisher Exact
Primary
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale | Grades (0-1) | 46.85 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale | Grades (2-4) | 53.15 Percentage of participants |
p-value: 0.176Fisher Exact
Secondary
Length of Inpatient Stay-Baseline COPD Related Utilization Counts
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Length of Inpatient Stay-Baseline COPD Related Utilization Counts | 2.02 Days | Standard Deviation 8.34 |
| Fluticasone /Salmeterol | Length of Inpatient Stay-Baseline COPD Related Utilization Counts | 1.57 Days | Standard Deviation 6.18 |
Secondary
Length of Stay in Hospital-Baseline All Cause Utilization Counts
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Length of Stay in Hospital-Baseline All Cause Utilization Counts | 3.51 Days | Standard Deviation 10.09 |
| Fluticasone /Salmeterol | Length of Stay in Hospital-Baseline All Cause Utilization Counts | 3.95 Days | Standard Deviation 9.57 |
Secondary
Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics | 2.53 Scores on a scale | Standard Deviation 1.91 |
| Fluticasone /Salmeterol | Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics | 2.49 Scores on a scale | Standard Deviation 1.74 |
p-value: 0.732t-test, 2 sided
Secondary
Mean Count of Unique COPD Medications-Baseline COPD Medication
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Count of Unique COPD Medications-Baseline COPD Medication | 0.99 Medications | Standard Deviation 0.1 |
| Fluticasone /Salmeterol | Mean Count of Unique COPD Medications-Baseline COPD Medication | 0.99 Medications | Standard Deviation 0.09 |
p-value: 0.692t-test, 2 sided
Secondary
Mean Count of Unique Medications-Baseline All Cause Utilization
A count of unique medications filled in the 12-month Baseline period was calculated. The mean values has been presented.
Time frame: 12 months
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Count of Unique Medications-Baseline All Cause Utilization | 13.39 Medications | Standard Deviation 5.99 |
| Fluticasone /Salmeterol | Mean Count of Unique Medications-Baseline All Cause Utilization | 14.52 Medications | Standard Deviation 6.67 |
p-value: 0.013t-test, 2 sided
Secondary
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts | Ambulatory visits | 26.79 Hospital visits | Standard Deviation 18.1 |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts | Outpatient visits | 10.04 Hospital visits | Standard Deviation 10.34 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts | Emergency room visits | 1.18 Hospital visits | Standard Deviation 1.9 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts | Office visits | 15.54 Hospital visits | Standard Deviation 12.42 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts | Ambulatory visits | 25.51 Hospital visits | Standard Deviation 17.76 |
Secondary
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts | Outpatient visits | 0.91 Hospital visits | Standard Deviation 2.25 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts | Emergency room visits | 0.21 Hospital visits | Standard Deviation 0.54 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts | Office visits | 1.47 Hospital visits | Standard Deviation 1.72 |
| Fluticasone /Salmeterol | Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts | Ambulatory visits | 2.38 Hospital visits | Standard Deviation 3.02 |
Secondary
Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
Mean number of inpatient admissions during the 12 months Baseline period has been presented.
Time frame: 12 months
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts | 0.40 Inpatient Hospital Admissions | Standard Deviation 0.76 |
| Fluticasone /Salmeterol | Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts | 0.47 Inpatient Hospital Admissions | Standard Deviation 0.85 |
Secondary
Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
Mean number of Baseline COPD related inpatient admissions during the 12 months Baseline period has been presented.
Time frame: 12 months
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts | 0.17 Admissions | Standard Deviation 0.5 |
| Fluticasone /Salmeterol | Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts | 0.17 Admissions | Standard Deviation 0.48 |
Secondary
Mean Total Baseline All Cause Healthcare Costs
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Total Baseline All Cause Healthcare Costs | 19915.66 US Dollars | Standard Deviation 31213.46 |
| Fluticasone /Salmeterol | Mean Total Baseline All Cause Healthcare Costs | 17591.88 US Dollars | Standard Deviation 21533.79 |
Secondary
Mean Total Baseline COPD-related Healthcare Costs
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
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Total Baseline COPD-related Healthcare Costs | 5008.86 US Dollars | Standard Deviation 11551.58 |
| Fluticasone /Salmeterol | Mean Total Baseline COPD-related Healthcare Costs | 3797.44 US Dollars | Standard Deviation 7246.79 |
Secondary
Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
A count of unique COPD dispensings for all medications filled in the 12-month Baseline period was calculated.
Time frame: 12 months
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications | 2.50 Medications dispensing | Standard Deviation 1.4 |
| Fluticasone /Salmeterol | Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications | 1.76 Medications dispensing | Standard Deviation 1.11 |
p-value: <0.001t-test, 2 sided
Secondary
Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
A count of unique dispensing's for all medications filled in the 12-month Baseline period was calculated.
Time frame: 12 months
Population: All enrolled Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Umeclidinium/Vilanterol | Mean Total Number of Medications Dispensing-Baseline All Cause Utilization | 43.55 Medications dispensing | Standard Deviation 26.15 |
| Fluticasone /Salmeterol | Mean Total Number of Medications Dispensing-Baseline All Cause Utilization | 46.22 Medications dispensing | Standard Deviation 29.46 |
p-value: 0.178t-test, 2 sided
Secondary
Number of Participants With Atleast One Baseline COPD Exacerbation
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
Population: All enrolled Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Umeclidinium/Vilanterol | Number of Participants With Atleast One Baseline COPD Exacerbation | 164 Participants |
| Fluticasone /Salmeterol | Number of Participants With Atleast One Baseline COPD Exacerbation | 184 Participants |
Secondary
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD A with mMRC only | 43.37 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD B with mMRC only | 33.42 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD C with mMRC only | 8.42 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD D with mMRC only | 14.80 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD A with CAT only | 11.73 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD B with CAT only | 65.05 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD C with CAT only | 1.53 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD D with CAT only | 21.68 Percentage of participants |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Umeclidinium/Vilanterol | 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 |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD C with mMRC and CAT | 1.51 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD B with mMRC only | 38.54 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD A with mMRC only | 37.28 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD C with CAT only | 1.51 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD B with mMRC or CAT | 65.99 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD C with mMRC only | 9.57 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD D with CAT only | 22.67 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD D with mMRC only | 14.61 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD D with mMRC or CAT | 22.67 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD A with CAT only | 9.82 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD A with mMRC and CAT | 9.82 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification | GOLD B with CAT only | 65.99 Percentage of participants |
Secondary
Percentage of Participants With All Cause Healthcare Resource Utilization
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umeclidinium/Vilanterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Emergency room visits | 44.64 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Office visits | 98.72 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Ambulatory visits | 100.00 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Outpatient visits | 84.69 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Inpatient stays | 28.83 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Outpatient visits | 87.41 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Inpatient stays | 31.49 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Emergency room visits | 50.38 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Ambulatory visits | 100.00 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With All Cause Healthcare Resource Utilization | Office visits | 97.98 Percentage of participants |
Secondary
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
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
Population: All enrolled Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Umeclidinium/Vilanterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Emergency room visits | 10.71 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Office visits | 77.30 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Ambulatory visits | 83.93 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Outpatient visits | 39.03 Percentage of participants |
| Umeclidinium/Vilanterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Inpatient stay | 13.78 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Outpatient visits | 28.97 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Inpatient stay | 13.60 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Emergency room visits | 16.37 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Ambulatory visits | 75.57 Percentage of participants |
| Fluticasone /Salmeterol | Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization | Office visits | 61.46 Percentage of participants |