In pivotal clinical trials, DALIRESP demonstrated a statistically significant reduction in the rate of exacerbations and a modest improvement in lung function for the target patient population.
The efficacy of DALIRESP 500 mcg once daily in reducing moderate or severe COPD exacerbations was established in two 1-year placebo-controlled trials involving patients with severe COPD associated with chronic bronchitis and a history of exacerbations. In these trials, DALIRESP demonstrated a statistically significant 15% and 18% reduction in the rate of exacerbations compared to placebo. While not a bronchodilator, treatment also resulted in a modest but statistically significant average improvement in pre-bronchodilator FEV1 (lung function) of approximately 50 mL across four 1-year trials.

