At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,876 enrolled
Drug / intervention
BFF MDI (PT009) 320/9.6 μg +2 moredrug
Likely dose
BFF MDI (PT009) 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 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
In Brief
A Phase 3 clinical trial evaluating BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg, and 1 other intervention for Chronic Obstructive Pulmonary Disorder. Completed, enrolled 1,876 participants across 282 sites in 19 countries.
Detailed Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disorder
CountriesArgentina, Austria, Belgium, Brazil, Canada, Chile, Denmark, Germany, Italy, Mexico, Norway, Peru, Puerto Rico, Russia, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartApr 2016
Primary CompletionApr 2018
TodayJul 2026
First PostedApr 4, 2016
Enrollment StartApr 29, 2016
Primary CompletionApr 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.2 years ago
Interventions
BFF MDI (PT009) 320/9.6 μgdrug
Blinded Treatment
BFF MDI (PT009) 160/9.6 μgdrug
Blinded Treatment
FF MDI (PT005) 9.6 μgdrug
Blinded Treatment