Study Shows Drug Combo May Benefit Patients with Moderate-to-Severe Asthma

Roflumilast is known to treat mild asthma, used as a combo therapy it could also treat more severe cases
Roflumilast is known to treat mild asthma, used as a combo therapy it could also treat more severe cases

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).

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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 jacioline.org.

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