At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 237 enrolled
Drug / intervention
PT005 MDI +3 moredrug
Likely dose
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)from 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, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating PT005 MDI, PT001 MDI, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 237 participants across 20 sites in 3 countries.
Detailed Summary
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesAustralia, New Zealand, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedMay 9, 2011
Enrollment StartMay 1, 2011
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.1 years ago
Interventions
PT005 MDIdrug
PT005 MDI administered as two puffs BID for 14 days
PT001 MDIdrug
PT001 MDI administered as two puffs BID for 14 days
PT003 MDIdrug
PT003 MDI administered as two puffs BID for 14 days
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)drug
Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days