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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 e8 (July 2016) DOI: /j.jaci Copyright © 2016 The Authors Terms and Conditions
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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 , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions
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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 , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions
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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 , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions
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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 , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions
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