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

Completed

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT03543176

Run by

GlaxoSmithKline

People needed

789

Starts

2018-05-31

Expected to finish

2019-08-21

Last updated by the study team

2020-08-05

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=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.

You may not qualify if…

• >=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

Where it is running

• GSK Investigational Site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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