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

NCT ID: NCT03543176

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 789 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2019-08-21

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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 .

UMEC/VI

Intervention Type: OTHER

UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .

CAT

Intervention Type: OTHER

Questionnaire used to asses Condition-related well-being, for COPD subjects.

mMRC

Intervention Type: OTHER

Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.

Ellipta

Intervention Type: DEVICE

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.

FLUT/SAL

Intervention Type: OTHER

FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.

CAT

Intervention Type: OTHER

Questionnaire used to asses Condition-related well-being, for COPD subjects.

mMRC

Intervention Type: OTHER

Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.

Diskus

Intervention Type: DEVICE

It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.

Interventions

UMEC/VI

UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .

Intervention Type: OTHER

FLUT/SAL

FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.

Intervention Type: OTHER

CAT

Questionnaire used to asses Condition-related well-being, for COPD subjects.

Intervention Type: OTHER

mMRC

Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.

Intervention Type: OTHER

Ellipta

It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.

Intervention Type: DEVICE

Diskus

It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UnitedHealth Group

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

208782

Identifier Type: -

Identifier Source: org_study_id