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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: FLUT/SAL; Other: UMEC/VI; Device: Ellipta; Other: CAT; Device: Diskus; Other: mMRC

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03543176

208782

Details and patient eligibility

About

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.

Enrollment: 789 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

789 participants in 2 patient groups

UMEC/VI

Description:

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 .

Treatment:

Device: Ellipta

Other: CAT

Other: mMRC

Other: UMEC/VI

FLUT/SAL

Description:

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.

Treatment:

Other: CAT

Other: FLUT/SAL

Device: Diskus

Other: mMRC