Roflumilast combined with montelukast versus montelukast alone as add-on treatment in patients with moderate-to-severe asthma Eric D. Bateman, MD, Udo-Michael.

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Presentation transcript:

Roflumilast combined with montelukast versus montelukast alone as add-on treatment in patients with moderate-to-severe asthma Eric D. Bateman, MD, Udo-Michael Goehring, MD, Frank Richard, MD, Henrik Watz, MD Journal of Allergy and Clinical Immunology Volume 138, Issue 1, Pages 142-149.e8 (July 2016) DOI: 10.1016/j.jaci.2015.11.035 Copyright © 2016 The Authors Terms and Conditions

Fig 1 Schematic of the crossover study design: 2- to 4-week screening period, followed by two 4-week double-blind treatment periods separated by a washout period of 4 weeks. A final visit took place 7 to 21 days after the second treatment period. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 142-149.e8DOI: (10.1016/j.jaci.2015.11.035) Copyright © 2016 The Authors Terms and Conditions

Fig 2 Disposition of patients. A, Roflumilast (500 μg) plus montelukast (10 mg) once daily (QD). B, Placebo plus montelukast (10 mg) QD. Journal of Allergy and Clinical Immunology 2016 138, 142-149.e8DOI: (10.1016/j.jaci.2015.11.035) Copyright © 2016 The Authors Terms and Conditions

Fig 3 A, Mean (SD) change from baseline in prebronchodilator FEV1 (in liters) in treatment periods 1 and 2 (full analysis set). B, Mean (SD) change from baseline to week 4 in FVC in treatment periods 1 and 2. C, Mean change from baseline to week 4 in prebronchodilator PEF (in liters). D, Improvement (reduction) in ACQ-7 score (mean change from baseline) by visit comparing montelukast plus placebo and montelukast plus roflumilast. MCID, Minimal clinically important difference. Journal of Allergy and Clinical Immunology 2016 138, 142-149.e8DOI: (10.1016/j.jaci.2015.11.035) Copyright © 2016 The Authors Terms and Conditions

Fig 4 Changes in urinary LTE4 values (SD) during treatment sequences AB (n = 32) and BA (n = 32). A, Roflumilast (500 μg once daily) + montelukast (10 mg once daily); B, placebo plus montelukast (10 mg once daily). Mean (SD) values were measured at baseline period 1, day 28, baseline period 2, and day 84. Journal of Allergy and Clinical Immunology 2016 138, 142-149.e8DOI: (10.1016/j.jaci.2015.11.035) Copyright © 2016 The Authors Terms and Conditions