drugset / Trial / NCT03262012

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

NCT03262012

Phase 3 Completed 416 enrolled Pearl Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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®

Timeline

Start
2016-08-09
Primary completion
2018-06-15
Completion
2018-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule Inhaled
Subject Formoterol Other / unclassified Inhaled
Subject Glycopyrronium Unknown Inhaled