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

July 20, 2020 updated by: GlaxoSmithKline

Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
789

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27709
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include Medicare Advantage (Medicare) health plan members with evidence of COPD, in the 12 months prior to sample identification and evidence of treatment with UMEC/VI or FLUT/SAL, single-inhaler dual therapy in the six months prior to sample identification. All adults (male and female) subjects with age, greater than or equal to 65 years will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: 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.
Other: FLUT/SAL
FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.
Device: Diskus
It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
Time Frame: 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.
Day 1
Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
Time Frame: 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).
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
Time Frame: 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.
12 months
Mean Count of Unique Medications-Baseline All Cause Utilization
Time Frame: 12 months
A count of unique medications filled in the 12-month Baseline period was calculated. The mean values has been presented.
12 months
Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
Time Frame: 12 months
A count of unique dispensing's for all medications filled in the 12-month Baseline period was calculated.
12 months
Percentage of Participants With All Cause Healthcare Resource Utilization
Time Frame: 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.
12 months
Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
Time Frame: 12 months
Mean number of inpatient admissions during the 12 months Baseline period has been presented.
12 months
Length of Stay in Hospital-Baseline All Cause Utilization Counts
Time Frame: 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.
12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
Time Frame: 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.
12 months
Mean Total Baseline All Cause Healthcare Costs
Time Frame: 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.
12 months
Mean Count of Unique COPD Medications-Baseline COPD Medication
Time Frame: 12 months
A count of unique COPD medications filled in the 12-month Baseline period was calculated. The mean values have been presented.
12 months
Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
Time Frame: 12 months
A count of unique COPD dispensings for all medications filled in the 12-month Baseline period was calculated.
12 months
Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
Time Frame: 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 months
Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
Time Frame: 12 months
Mean number of Baseline COPD related inpatient admissions during the 12 months Baseline period has been presented.
12 months
Length of Inpatient Stay-Baseline COPD Related Utilization Counts
Time Frame: 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.
12 months
Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
Time Frame: 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.
12 months
Mean Total Baseline COPD-related Healthcare Costs
Time Frame: 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.
12 months
Number of Participants With Atleast One Baseline COPD Exacerbation
Time Frame: 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.
12 months
Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Optum-data vendor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 208782

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Date Request site.

IPD Sharing Time Frame

IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.

IPD Sharing Access Criteria

Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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