At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 8,588 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, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
In Brief
A Phase 3 clinical trial evaluating BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, and 2 other interventions for COPD. Completed, enrolled 8,588 participants across 741 sites in 26 countries.
Detailed Summary
This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJun 2015
Primary CompletionJul 2019
TodayJul 2026
First PostedJun 8, 2015
Enrollment StartJun 30, 2015
Primary CompletionJul 26, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.1 years ago
Interventions
BGF MDI 320/14.4/9.6 μgdrug
Budensonide, Glycopyrronium, and Formoterol Fumarate
GFF MDI 14.4/9.6 μgdrug
Glycopyrronium, and Formoterol Fumarate
BGF MDI 160/14.4/9.6 μgdrug
Budensonide, Glycopyrronium, and Formoterol Fumarate
BFF MDI 320/9.6 μgdrug
Budensonide, and Formoterol Fumarate