At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Aclidinium Bromide and Placebo for COPD and 2 related conditions. Completed, enrolled 3,635 participants across 468 sites in 2 countries.
Detailed Summary
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. This study is 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.
Study Details
Timeline
Interventions
400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)