At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 140 enrolled
Drug / intervention
PT001 MDI +2 moredrug
Likely dose
Tiotropium Bromide 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 and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
In Brief
A Phase 2 clinical trial evaluating PT001 MDI, Tiotropium Bromide, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 140 participants across 10 sites.
Detailed Summary
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedMar 2012
Primary CompletionAug 2012
TodayJul 2026
First PostedMar 29, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.3 years ago
Interventions
PT001 MDIdrug
Administered as two puffs BID for 14 days
Tiotropium Bromidedrug
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
PT001 Placebo MDIdrug