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Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®

COPD Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control

Clinical Trial Summary

A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®

Clinical Trial Description

This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03262012
Study type Interventional
Source Pearl Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date August 9, 2016
Completion date June 15, 2018
View Details
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