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)
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)
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.
Inclusion Criteria:
1. Male or female outpatients ≥ 40 years of age
2. Current or former cigarette smokers with a smoking history of at least 10 pack-years
3. A diagnosis of stable, moderate to very severe COPD (GOLD, 2015) with a post-bronchodilator FEV < 80% FEV1/forced vital capacity (FVC) ratio < 70%
4. Must have at least one of the following 4 criteria:
Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis)
Documented coronary artery disease (angina, MI, angioplasty/stent/bypass)
Documented peripheral vascular disease or history of claudication
At least 2 of the following atherothrombotic risk factors as determined by the PI:
5. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)
6. Able to perform pulmonary function test (PFT) maneuvers and follow study procedures
7. Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (HCG) pregnancy test at Visit 1A and be practicing medically acceptable method of contraception. Otherwise, female patients should be at least 1 year postmenopausal, surgically sterile (defined as having a hysterectomy or tubal ligation).
8. Should understand study procedures and be willing to participate in the study as indicated by signing the ICF
Exclusion Criteria:
Marshall, Louisiana 75670, United States
Hopewell Jct, New York 12533, United States