Boehringer's Stiolto Respimat misses in Phase III for COPD
In March, Boehringer Ingelheim GmbH (Ingelheim, Germany) reported data from the Phase III DYNAGITO trial in 7,880 patients with chronic obstructive pulmonary disease (COPD) showing that Stiolto Respimat tiotropium/olodaterol (Inspiolto Respimat, Spiolto Respimat) missed the primary endpoint of decreasing the rate of moderate to severe COPD exacerbations vs. Spiriva Respimat tiotropium bromide. Stiolto Respimat non-significantly decreased the rate by 7% vs. Spiriva Respimat (p=0.0498). The predefined threshold for significance was a p-value of ≤0.01. Data were published in The Lancet Respiratory Medicine.
Patients in the double-blind, international trial received once-daily 5 μg/5 μg tiotropium/olodaterol or 5 μg tiotropium for 52 weeks...
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