At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 159 enrolled
Drug / intervention
PT003 +3 moredrug
Likely dose
Tiotropium inhalation powder 18 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, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
In Brief
A Phase 2 clinical trial evaluating PT003, PT001, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 159 participants across 19 sites.
Detailed Summary
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedApr 2012
Primary CompletionSep 2012
Study CompletionOct 2012
TodayJul 2026
First PostedApr 27, 2012
Enrollment StartApr 1, 2012
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.2 years ago
Interventions
PT003drug
PT003 MDI administered as two puffs BID for 7 days
PT001drug
PT001 MDI administered as two puffs BID for 7 days
PT005drug
PT005 MDI administered as two puffs BID for 7 days
Tiotropium inhalation powderdrug
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days