Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).

Timeline

Start

2009-03

Primary completion

2009-09

Completion

2009-09

Outcome

Met primary endpoint

paper All 4 doses of GP MDI showed statistically superior efficacy compared with Placebo MDI for peak FEV1 (differences of 146 to 248 mL; P<.001) PMID 25027304 ↗

Publications

• Rennard S, Fogarty C, Reisner C, Fernandez C, Fischer T, Golden M, Rose ES, Darken P, Tardie G, Orevillo C. Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2014 Jul 16;14:118. doi: 10.1186/1471-2466-14-118.

Drugs

Indications