At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
In Brief
A Phase 2 clinical trial evaluating PT003 MDI, PT005 MDI, and 4 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 118 participants across 16 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Study Details
Timeline
Interventions
Inhaled PT003 MDI administered as two puffs BID for 7 days
Inhaled PT005 MDI administered as two puffs BID for 7 days
Inhaled placebo administered as two puffs BID for 7 days
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Inhaled PT001 MDI administered as two puffs BID for 7 days