New data indicates various doses of roflumilast reduced allergen-induced airway inflammation in asthma patients.
“The studies presented here show that roflumilast has no acute bronchodilator actions in patients with mild to moderate asthma,” Philip Bardin, PhD, the director of the lung and sleep unit at Monash Health in Australia, and colleagues wrote. “This finding is not unexpected given that roflumilast is an anti-inflammatory agent and not a direct bronchodilator. However, the effects of roflumilast on airflow limitation in the allergen challenge model are notable.”
Bardin and colleagues reviewed data from eight placebo controlled, double blind phase 1 to 3 studies conducted across 14 sites in North America, Europe and South Africa from 1997 to 2005 to analyze the efficacy and mechanism of action of roflumilast in patients with asthma.
The analysis included 197 patients aged 18 to 70 years who either received 250 µg, 500 µg or 1,000 µg of roflumilast or placebo.
In one of the included studies, late asthmatic reaction reduced by 43% in patients treated with 500 µg of roflumilast(n = 20) compared with placebo (n = 21) (P = .001). Late asthmatic reaction also reduced by 27% in patients treated with 250 µg (n = 21) compared with placebo (P = .011).