Boehringer Ingelheim announced results from the Phase 3 VIVACITO study 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).

In the VIVACITO study, 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: placebo, olodaterol 5mcg, tiotropium 2.5mcg or tiotropium 5mcg, and T+O FDC 2.5/5mcg or T+O FDC 5/5mcg. The primary endpoint was forced expiratory volume in one second (FEV1).

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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. The FEV1 compared to monotherapies was 0.107–0.124L (P<0.0001) and 0.110–0.127L (P<0.0001) in T+O 2.5/5mcg and T+O 5/5mcg, respectively. Compared to placebo, the FEV1 was 0.277L (P<0.0001) and 0.280L (P<0.0001) in T+O 2.5/5mcg and T+O 5/5mcg, respectively.

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.

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