Phase 4 Trial Finds Tudorza Safe and Effective for COPD Patients with Cardiovascular Disease
Long-term use of Tudorza (aclidinium bromide) can significantly and safely reduce exacerbations in people with moderate to severe chronic obstructive pulmonary disease and cardiovascular disease or risk factors, findings in a Phase 4 post-marketing study show.
Tudorza, developed by AstraZeneca, contains the long-acting muscarinic antagonist (LAMA) aclidinium bromide, a bronchodilator that helps to open the airways to make it easier to breathe. In the United States, Tudorza is marketed by Circassia Pharmaceuticals. Under a collaboration agreement, AstraZeneca is responsible for the treatment’s clinical evaluationt.
The ASCENT trial (NCT01966107) included 3,635 COPD patients with cardiovascular risk factors, who were treated with 400 µg of aclidinium or placebo via Pressair inhaler, twice daily, for up to 36 months. Set to conclude this month, patients were treated at 470 clinical sites in the United States and Canada.
Both trial primary efficacy endpoints were achieved. Tudorza-treated patients experienced significantly less COPD flares compared to those in the placebo group during the first year of treatment. And it seen to be safe to use in those with cardiovascular disease or at high risk for such disease — a common comorbidity in COPD patients. No real differences in the time to the first major adverse cardiovascular event was seen among treated patients and those given placebo.
“The ASCENT data demonstrate that Tudorza, when added to background therapy, reduces exacerbation rates in patients with cardiovascular disease or risk factors and adds to the established efficacy and safety profile of aclidinium bromide,” Steve Lewington, global medicine leader of respiratory business at AstraZeneca, said in a press release.
AstraZeneca expects to soon submit to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) “for an expanded label for Tudorza in the U.S.” Lewington said. The company hopes to include this high-risk population in those using Tudorza to treat COPD symptoms.
Analysis of the full trial data is ongoing. The companies expect to present top-line ASCENT trial data at upcoming medical conferences.
Tudorza was approved by the FDA in 2012 as a twice-daily dry powder inhaler for long-term maintenance treatment of bronchospasm associated with COPD.