NCT03543176

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 789 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-05-31
• Primary completion: 2019-08-21
• Completion: 2019-08-21
• First posted: 2018-06-01
• Last updated: 2020-08-05
• Results posted: 2020-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study