At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,389 enrolled
Drug / intervention
BFF MDI 320/9.6 μg +4 moredrug
Likely dose
BFF MDI 320/9.6 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, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
In Brief
A Phase 3 clinical trial evaluating BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and 3 other interventions for Chronic Obstructive Pulmonary Disorder. Completed, enrolled 2,389 participants across 259 sites in 8 countries.
Detailed Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disorder
CountriesCanada, Czechia, Germany, Hungary, Poland, Russia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartMay 2016
Primary CompletionDec 2017
TodayJul 2026
First PostedMay 10, 2016
Enrollment StartMay 31, 2016
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.1 years ago
Interventions
BFF MDI 320/9.6 μgdrug
Blinded Treatment
BFF MDI 160/9.6 μgdrug
Blinded Treatment
FF MDI 9.6 μgdrug
Blinded Treatment
BD MDI 320 μgdrug
Blinded Treatment
Symbicort® TBH 400/12 μg BIDdrug
Open Label