Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 6/21/2018 |
| Start Date: | May 31, 2018 |
| End Date: | May 1, 2019 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
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.
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.
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
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