Boehringer Ingelheim today presented results of the VIVACITO® (NCT01559116) study, the first Phase 3 data to be reported from the TOviTO® clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T+O FDC) delivered via the Respimat® inhaler on lung function in people with chronic obstructive pulmonary disease (COPD). These data were presented as a late-breaking poster at the American Thoracic Society (ATS) 2014 International Conference.
Once-daily T+O FDC is an investigational treatment that combines the long-acting muscarinic antagonist (LAMA)tiotropium with olodaterol, an investigational long-acting beta agonist (LABA), delivered via the Respimat® inhaler, a propellant-free inhaler that generates a soft, slow-moving mist. The Phase 3 clinical trial program for T+O FDC, TOviTO®, is a large global program that includes more than 8,000 patients with COPD.
“The improvement in lung function seen in the VIVACITO® study suggests that T+O FDC has the potential to become a viable once-daily COPD treatment,†said Klaus F. Rabe, Professor of Pulmonary Medicine at the University of Kiel and Director of the Department of Pneumology at Clinic Grosshansdorf in Germany. “This is good news as we have learned that not all patients respond to just one therapy and more options are needed, particularly considering the incidence of COPD is projected to increase worldwide in the coming decades.â€
VIVACITO® was a Phase 3 study in which 219 patients with moderate to very severe COPD were randomized to receive four of the following treatments for six weeks, each with a three-week period of no treatment in between: (1) placebo; (2) olodaterol 5 mcg; (3) tiotropium 2.5 mcg or tiotropium 5 mcg; (4) T+O FDC 2.5/5 mcg or T+O FDC 5/5 mcg. The primary endpoint was forced expiratory volume in one second (FEV1), a measure of the amount of air exhaled in one second, over 24 hours after six weeks of treatment. Secondary endpoints included additional tests measuring breathing over 24 hours.
The 24-hour time profiles for both FDCs were very similar and showed improvements in lung function, as measured by FEV1, compared with placebo and monotherapies over 24 hours. Both T+O FDCs were statistically significantly superior to placebo.