Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium bromide and Vilanterol using Pooled Data from three Phase III (Fluticasone Furoate/Umeclidinium bromide/Vilanterol) studies (200812, CTT116853 and CTT116855) in adults with Chronic Pulmonary Obstructive Disease

Trial description: This will be a POP PK analysis of FF, UMEC and VI using pooled data from three phase III studies (200812, CTT116853 and CTT116855) in a subset of subjects with COPD. COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms. The PK of FF, UMEC and VI have been previously characterized in COPD following monotherapy and when administered as dual combination using non-linear mixed effects modeling (NONMEM). However, this analysis is planned to assess the effect on PK as well as effect of covariates on PK when FF, UMEC and VI will be administered in using a single inhaler. The influence of subject demographics, Baseline characteristics and co-medication on the PK of FF, UMEC and VI will also be investigated. Studies 200812, CTT116853 and CTT116855 are phase III, multicenter, randomized, double blind, parallel-group studies in adults with COPD evaluating the triple therapy of inhaled FF/UMEC/VI in a single inhaler. Sparse plasma samples (subset A) were collected in all 3 studies in addition to serial plasma samples (subset B) from 2 studies in a subset of the population for POP PK analysis. A subset of 74 subjects from study CTT116853, 180 subjects from study 200812 and 300 subjects from study CTT116855 will be included in this analysis.