At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 185 enrolled
Drug / intervention
PT003 +2 moredrug
Likely dose
Not stated in 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), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
In Brief
A Phase 2 clinical trial evaluating PT003, PT001, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 185 participants across 13 sites.
Detailed Summary
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedMay 9, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.1 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