CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
BGF MDI (PT010) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03262012
NCT03262012Phase 3Completed
CompareCT.gov

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

Pearl Therapeutics, Inc.·interventional·Posted Aug 25, 2017·Updated May 13, 2020

In Brief

A Phase 3 clinical trial evaluating BGF MDI (PT010), GFF MDI (PT003), and 2 other interventions for COPD. Completed, enrolled 416 participants across 79 sites.

Detailed 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®

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2017
Enrollment StartAug 9, 2016
Primary CompletionJun 15, 2018
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago

Interventions

BGF MDI (PT010)drug

Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010

GFF MDI (PT003)drug

Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003

BFF MDI (PT009)drug

Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009

Symbicort® Turbohaler® Inhalation Powderdrug

Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler