At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 627 enrolled
Drug / intervention
BGF MDI 320/14.4/9.6 μg +2 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, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 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 14.4/9.6 μg, and 1 other intervention for COPD. Completed, enrolled 627 participants across 64 sites.
Detailed Summary
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartAug 2015
First PostedSep 2015
Primary CompletionSep 2017
TodayJul 2026
First PostedSep 1, 2015
Enrollment StartAug 10, 2015
Primary CompletionSep 12, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.8 years ago
Interventions
BGF MDI 320/14.4/9.6 μgdrug
Budesonide, Glycopyrronium, and Formoterol Fumarate
GFF MDI 14.4/9.6 μgdrug
Glycopyrronium and Formoterol Fumarate
BFF MDI 320/9.6 μgdrug
Budesonide and Formoterol Fumarate