Center for Global Research Data

Development and validation of a prediction model for the indication of inhaled corticosteroid (ICS) in patients with chronic obstructive pulmonary disease (COPD)

Lead Investigator: Yeon-Mok Oh, Asan Medical Center
Title of Proposal Research: Development and validation of a prediction model for the indication of inhaled corticosteroid (ICS) in patients with chronic obstructive pulmonary disease (COPD)
Vivli Data Request: 6712
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. COPD is well known as a clinical syndrome characterized by chronic respiratory symptoms, structural pulmonary abnormalities, lung function impairment, or any combination of these. Inhaled drugs, including long-acting bronchodilators and steroids, are mainly used for COPD pharmacotherapy. Among them, the role of inhaled corticosteroid (ICS) for COPD patients are less known than bronchodilators. Pneumonia, which can be detrimental for COPD patients, is the well-known side effect for ICS. Therefore, when prescribing ICS to COPD patients, its positive effects and side effects must be fully considered. In this study, we intend to create a model that predicts COPD patients who can expect a positive effect when using ICS. Through this study, we expect to improve the quality of life and provide better therapeutic effects for patients requiring ICS in COPD patients.

Requested Studies:

A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Data Contributor: GlaxoSmithKline
Study ID: NCT02164513
Sponsor ID: CTT116855