The effect of roflumilast on exacerbations in patients with severe COPD treated with combination therapy, inhalation
Abstract
The REACT trial was a multicentric double blinded placebo controled trial in 1935 patients with severe chronic obstructive pulmonary disease (COPD) with bronchitic symptoms and frequent exacerbations, who were treated with combined therapy of inhaled corticosteroids and long acting beta agonists (LABA). Treatment with tiotropium was alloved too.
The trial lasted for a year and the patients were randomised into two groups. Actively treated group received roflumilast on top of the ongoing medication, control group received placebo the same way.
Primary endpoint were moderate and severe exacerbations, which occured less in actively treated group by 13,2% according to the Poisson regressive analysis. According to predefined negative binomic regression there was even more significant decrease in primary endpoint by 14,2%.
Adverse events were reported in 67% of patients in actively treated group and in 59% of patients of placebo group. Adverse events leading to study discontinuation were more frequent in roflumilast group.
Most commonly reported adverse events were COPD exacerbation and pneumonia. There were 17 deaths in roflumilast group and 18 in placebo group.
The results of this trial indicate the effect of roflumilast on decrease of severe exacerbations in patients with severe COPD and chronic bronchitis, who are at risk of serious exacerbations despite the therapy with inhaled corticosteroids and LABA, even in combination with tiotropium.