Boehringer Ingelheim announced findings from the DYNAGITO trial that compared Stiolto Respimat (tiotropium bromide, olodaterol) vs Spiriva Respimat (tiotropium bromide) in the reduction of chronic obstructive pulmonary disease (COPD) exacerbations. The study has been published in The Lancet Respiratory Medicine.
In the 52-week, double-blind, randomized, parallel-group, active-controlled DYNAGITO study (N=7,880), study patients were assigned Stiolto Respimat or Spiriva Respimat once daily while continuing background inhaled corticosteroid therapy. The primary endpoint was rate of moderate-to-severe COPD exacerbations from first dose of study drug to 1 day after final dose.
The data showed treatment with Stiolto Respimat led to a 7% reduction in moderate-to-severe COPD exacerbations compared with Spiriva Respimat alone (rate ratio [RR] 0.93, 99% CI: 0.85–1.02; P=0.0498); this finding did not meet statistical significance. Also, treatment with Stiolto Respimat significantly decreased COPD symptoms and improved health-related quality of life according to the COPD Assessment Test (CAT) vs Spiriva Respimat.
Stiolto Respimat, a anticholinergic + long-acting beta-2 agonist (LABA) combination, was approved by the Food and Drug Administration (FDA) as long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Spiriva Respimat is approved as long-term maintenance treatment of bronchospasm due to COPD, including chronic bronchitis and emphysema; to reduce exacerbations of COPD; and as long-term maintenance treatment of asthma in patients ≥6yrs of age. The Respimat inhalers deliver the drug into the lungs as a slow-moving mist and does not depend on patients’ inspiratory efforts.
Study authors concluded, “Combining tiotropium and olodaterol did not reduce exacerbation rate as much as expected compared with tiotropium alone.”
For more information visit thelancet.com.