At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 103 enrolled
Drug / intervention
PT001 MDI +2 moredrug
Likely dose
Ipratropium Bromide HFA Inhalation Aerosol 17 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, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
In Brief
A Phase 2 clinical trial evaluating PT001 MDI, Ipratropium Bromide HFA Inhalation Aerosol, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 103 participants across 8 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
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionOct 2011
TodayJul 2026
First PostedMay 9, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.1 years ago
Interventions
PT001 MDIdrug
PT001 MDI administered as two puffs BID for 7 days
Ipratropium Bromide HFA Inhalation Aerosoldrug
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
Placebo MDIother
Matching placebo to PT001 MDI administered as two puffs BID for 7 days