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

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).

Timeline

Start

2008-11

Primary completion

2009-05

Completion

2009-05

Outcome

Met primary endpoint

paper FF MDI 9.6 μg was non-inferior to FA for FEV1 AUC0-12 PMID 25060541 ↗

paper each FF MDI dose demonstrated superior efficacy versus placebo (P < .001 for all 3 doses). PMID 25060541 ↗

paper Peak and trough FEV1, forced vital capacity, peak expiratory flow rate, peak inspiratory capacity, and pharmacokinetics confirmed the primary endpoint PMID 25060541 ↗

Publications

• Quinn D, Seale JP, Reisner C, Fischer T, Golden M, Fernandez C, Darken P, St Rose E, Thomas M, Tardie G, Orevillo C. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir Med. 2014 Sep;108(9):1327-35. doi: 10.1016/j.rmed.2014.06.009. Epub 2014 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PT005	Unknown	2.4 ug	Inhaled
Subject	PT005	Unknown	4.8 ug	Inhaled
Subject	PT005	Unknown	9.6 ug	Inhaled
Subject	PT005	Unknown	12 ug	Inhaled

Indications