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

NCT03543176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 789

Last updated 2020-08-05

Study results available
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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

Interventions

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

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

Ellipta

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

DEVICE

Diskus

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-08-21
Completion
2019-08-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543176 on ClinicalTrials.gov