NCT01349868

PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (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 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT005 MDI	PT005 MDI taken as two inhalations
DRUG	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
DRUG	Formoterol Fumarate 24 μg (Foradil® Aerolizer®)	Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
OTHER	Placebo MDI	Matching placebo to PT005 MDI taken as two inhalations

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-05-09
• Last updated: 2012-09-12

Locations

3 sites across 1 country: United States