Roflumilast combined with montelukast improves lung function, symptom control, and urinary LTElevels in patients with moderate to severe asthma. The finding comes from a new Phase II randomized trial, published in the Journal of Allergy and Clinical Immunology.

Sixty-four patients were randomized into 2 treatment groups in the double-blind, placebo-controlled, multiple-dose, 2-sequence trial. The AB group received roflumilast 500μg  + montelukast 10mg followed by placebo + montelukast 10mg, while the BA group received placebo + montelukast 10mg followed by roflumilast 500μg + montelukast 10mg (sequence BA). All patients in the study were diagnosed as having bronchial asthma inadequately controlled by at least a medium-dose inhaled corticosteroid and a long-acting beta-agonist (ICS/LABA).

RELATED: Xolair to Expand Its Allergic Asthma Indication to Peds

The change in mean FEV1 between roflumilast + montelukast versus placebo + montelukast was 100mL (95% CI, 0.0219-0.1795;P = .013); the change in mean FEV1 was 171mL by the end of the second period.   Montelukast monotherapy achieved only small nonsignificant improvements. During roflumilast + montelukast treatment, improvements in home-monitored morning peak expiratory flow, daytime symptoms, and asthma control scores (ACQ-7) were also seen. Another striking find that corroborates the efficacy of roflumilast + montelukast, was the considerable decrease in Leukotriene E4 (LTE4) levels.

Roflumilast is a selective phosphodiesterase type 4 (PDE4) inhibitor thought to exert its therapeutic effect via increased intracellular cyclic AMP in lung cells. The study’s authors conclude that “the results lend support to the concept of combining anti-inflammatory drugs with different mechanisms of action in patients with more severe forms of asthma.”

For more information visit