Ascent COPD

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

Ascent COPD [NCT01966107]

Description: This study will be a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria (GOLD, 2011). The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations.

Drug: Aclidinium Bromide; Drug: Placebo

Primary Investigator: Dama

Drug/Device Information
Evaluate aclidinium bromide on cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD (Phase IV)
Aclidinium bromide is a long-acting muscarinic antagonist delivered by the Pressair® dry powder inhalation device (DPI)
Randomized (1:1) to Aclidinium bromide 400 µg or placebo twice a day. Rescue Albuterol/Salbutamol will be provided for all patients
Forest Research Institute, Inc.