Clinical trial NCT03543176: Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
Official title: Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Cohort
Chronic obstructive pulmonary disease
Observational
GOLD
Claims
Health plan recruitment
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: UnitedHealth Group
First posted: 2018-06-01
Enrollment: 789
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire
timeFrame: Day 1
measure: Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: Day 1
Secondary outcomes:
measure: Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics
timeFrame: 12 months
measure: Mean Count of Unique Medications-Baseline All Cause Utilization
timeFrame: 12 months
measure: Mean Total Number of Medications Dispensing-Baseline All Cause Utilization
timeFrame: 12 months
measure: Percentage of Participants With All Cause Healthcare Resource Utilization
timeFrame: 12 months
measure: Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts
timeFrame: 12 months
measure: Length of Stay in Hospital-Baseline All Cause Utilization Counts
timeFrame: 12 months
measure: Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts
timeFrame: 12 months
measure: Mean Total Baseline All Cause Healthcare Costs
timeFrame: 12 months
measure: Mean Count of Unique COPD Medications-Baseline COPD Medication
timeFrame: 12 months
measure: Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications
timeFrame: 12 months
measure: Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization
timeFrame: 12 months
measure: Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts
timeFrame: 12 months
measure: Length of Inpatient Stay-Baseline COPD Related Utilization Counts
timeFrame: 12 months
measure: Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts
timeFrame: 12 months
measure: Mean Total Baseline COPD-related Healthcare Costs
timeFrame: 12 months
measure: Number of Participants With Atleast One Baseline COPD Exacerbation
timeFrame: 12 months
measure: Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: