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NCT03543176 · ClinicalTrials.gov registry record
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 789
- Enrollment target
NCT03543176 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 789 participants.
The verdict
NCT03543176 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 789 participants
- Enrollment target
Study 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.
Interventions
- OTHER UMEC/VI
- OTHER FLUT/SAL
- OTHER CAT
- OTHER mMRC
- DEVICE Ellipta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 789 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2019-08-21 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03543176
The ClinicalTrials.gov registry entry for NCT03543176 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 789 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which UMEC/VI is the first listed.
NCT03543176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03543176 about?
NCT03543176 is a clinical study titled "Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness". 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...
What is the current status of trial NCT03543176?
This trial is currently completed. The enrollment target is 789 participants. The study started on 2018-05-31. Estimated completion is 2019-08-21.
What interventions are being tested in trial NCT03543176?
The interventions under investigation include: UMEC/VI (OTHER), FLUT/SAL (OTHER), CAT (OTHER), mMRC (OTHER), Ellipta (DEVICE).
Who is sponsoring clinical trial NCT03543176?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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