Stephen Rennard, MD, and his team focused their study on the assessment of long-term efficacy and safety of aclidinium bromide 400Âµg BID, an approved treatment option for patients afflicted with moderate to severe COPD.
At CHEST 2014, Stephen Rennard, MD, shared his research on the assessment of long-term efficacy and safety of aclidinium bromide 400µg BID, an approved treatment option for patients afflicted with moderate to severe Chronic Obstructive Pulmonary Disease COPD.
This open-label, 40-week extension study involved 454 patients required to complete a 12-week double-blind lead-in trial (ACCORD II), with 448 patients who continued to the extension. As the primary outcome, safety was analyzed through “adverse events of either new or increased intensity during the extension study”. Efficacy was assessed through an ANCOVA model.
Research found that the percentage of patients reporting ≥1 adverse events was similar among all groups—the most common (≥5%) was COPD exacerbation (18.1%) and upper respiratory tract infection (5.8%). Also, most were mild or moderate, and few were related to treatment. The most frequently reported potential anticholinergic events (≥1%) were urinary tract infection (2.5%) and constipation (1.3%), with similar rates among the various groups.
The study concluded aclidinium bromide 400µg was “well tolerated” over one year, with a safety profile similar among multiple treatment sequences. Although unexpected baseline imbalances across groups may have affected the observed treatment benefits of aclidinium bromide, improvements from baseline in efficacy endpoints during the lead-in were largely maintained over the 52 week timeline.