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Severe Asthma Research - March 2016

Christina E Ciaccio, MD, MSc

Christina E Ciaccio, MD, MSc
Allergist/Immunologist
Assistant Professor of Pediatrics
University of Chicago Medicine
Comer Children’s Hospital
Chicago, Illinois, United States

Roflumilast combined with montelukast versus montelukast alone as add-on treatment in patients with moderate-to-severe asthma

This study aimed to see if roflumilast, a selective inhibitor of phosphodiesterase 4 (PDE-4), in combination with montelukast, is an effective new therapeutic option for patients with moderate to severe asthma. This study randomized 64 adults with at least 6 months of uncontrolled asthma despite treatment with a medium dose combination inhaler in a randomized, placebo-controlled, multiple-dose, 2-sequence crossover protocol, with two 4-week treatment periods (roflumilast 500ug daily plus montelukast 10mg daily or placebo plus montelukast 10mg daily) separated by a 4-week washout period.  The results showed that roflumilast plus montelukast improved lung function (combination FEV1 improved 100mL in the first period and 171ml in the second period over montelukast alone), asthma symptoms, and asthma control over placebo plus montelukast.  No safety concerns were noted with administration of roflumilast over the known side effects seen in treatment of COPD.  Not only does this study propose a new therapeutic option for severe asthma; this study, also, offers proof of concept that combining medications aimed at different targets in the inflammatory process may provide substantial benefit to patients with severe asthma and should be considered in trials moving forward.

Bateman ED, Goehring UM, Richard F, Watz H. Roflumilast combined with montelukast versus montelukast alone as add-on treatment in patients with moderate-to-severe asthma. Journal of Allergy and Clinical Immunology 2016; article in press, published online ahead of print. (doi:10.1016/jaci.2015.11.035)

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