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

• ClinicalTrials.gov Identifier: NCT03543176
• Recruitment Status: Completed
• First Posted: June 1, 2018
• Results First Posted: August 5, 2020
• Last Update Posted: August 5, 2020
• Sponsor: GlaxoSmithKline
• Collaborator: Optum-data vendor
• Information provided by (Responsible Party): GlaxoSmithKline

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
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: August 21, 2019
• Actual Study Completion Date: August 21, 2019

Groups and Cohorts

Group/Cohort	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 [ 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.
2. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.

Biospecimen Retention:   None Retained

No bio-specimen samples were evaluated.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

United States, North Carolina

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)

Documents provided by GlaxoSmithKline:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2018

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03543176
• Other Study ID Numbers: 208782
• First Posted: June 1, 2018
• Results First Posted: August 5, 2020
• Last Update Posted: August 5, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Date Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.
• 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.
• URL: http://clinicalstudydatarequest.com

• 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; Respiratory Tract Diseases; Lung Diseases, Obstructive