At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,902 enrolled
Drug / intervention
BGF MDI 320/14.4/9.6 μg +3 moredrug
Likely dose
BGF MDI 320/14.4/9.6 μgfrom 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.
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating BGF MDI 320/14.4/9.6 μg, GFF MDI (PT003) 14.4/9.6 μg, and 2 other interventions for COPD. Completed, enrolled 1,902 participants across 190 sites in 4 countries.
Detailed Summary
Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesCanada, China, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartAug 2015
Primary CompletionJan 2018
TodayJul 2026
First PostedJul 14, 2015
Enrollment StartAug 10, 2015
Primary CompletionJan 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.0 years ago
Interventions
BGF MDI 320/14.4/9.6 μgdrug
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])
GFF MDI (PT003) 14.4/9.6 μgdrug
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
BFF MDI (PT009) 320/9.6 μgdrug
Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Symbicort® Turbuhaler® (TBH) Inhalation Powderdrug