NCT00880490

Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Five-period, Placebo and Active-controlled,Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of Inhaled PT005 in Patients With Moderate-to-Severe COPD, Compared to Open- Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (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 the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Inhaled PT005	single dose, inhaled
DRUG	Inhaled PT005	single dose, inhaled
DRUG	Inhaled PT005	single dose, inhaled
DRUG	Inhaled placebo	single dose, inhaled
DRUG	Formoterol Fumarate 12 mcg (Foradil Aerolizer)	single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-04-13
• Last updated: 2010-10-13

Locations

5 sites across 2 countries: Australia, New Zealand