NCT01043601

Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control

A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled, Multi-dose, Four-period, Cross-over Study of Two Doses of Formoterol Fumarate MDI (PT005; 7.2 and 9.6 µg Ex-actuator), Administered Twice Daily for 1 Week in Patients With Moderate to Very Severe COPD, Compared to Open Label Marketed Formoterol Fumarate Inhalation Powder (Foradil® Aerolizer®, 12 µg) as an Active Control

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Inhaled PT005	inhaled, twice daily for 1 week duration
DRUG	Inhaled Placebo	inhaled, twice daily for 1 week duration
DRUG	Formoterol Fumarate 12 µg (Foradil Aerolizer)	inhaled, twice daily for 1 week duration

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-01-07
• Last updated: 2014-07-11

Locations

1 site across 1 country: United States