How well does Daxas(Roflumilast) work?
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.
Therapeutic Effects and Efficacy
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.


