At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
GP MDI (PT001) 14.4 μg +1 moredrug
Likely dose
GP MDI (PT001) 14.4 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, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
In Brief
A Phase 3 clinical trial evaluating GP MDI (PT001) 14.4 μg and FF MDI (PT005) 9.6 μg for COPD, Chronic Obstructive Pulmonary Disease. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartDec 2016
Primary CompletionMay 2018
TodayJul 2026
First PostedOct 18, 2016
Enrollment StartDec 29, 2016
Primary CompletionMay 28, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.7 years ago
Interventions
GP MDI (PT001) 14.4 μgdrug
Glycopyrronium
FF MDI (PT005) 9.6 μgdrug
Formoterol Fumarate