NCT01085045

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT003 MDI	Inhaled PT003 MDI administered as two puffs BID for 7 days
DRUG	PT005 MDI	Inhaled PT005 MDI administered as two puffs BID for 7 days
DRUG	Placebo MDI	Inhaled placebo administered as two puffs BID for 7 days
DRUG	Tiotropium bromide 18 μg (Spiriva Handihaler®)	Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
DRUG	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
DRUG	PT001 MDI	Inhaled PT001 MDI administered as two puffs BID for 7 days

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-03-11
• Last updated: 2017-04-26
• Results posted: 2017-04-26

Locations

16 sites across 3 countries: United States, Australia, New Zealand