Dataset from A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

This is a multi-center, randomized, double-blind, parallel group, chronic dosing,
active-controlled, 28-week safety extension study of the two pivotal 24-week safety and
efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the
long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF)
combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to
very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included
as an active control. To be eligible for this study, a subject must complete participation in
Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).