Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group,

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Fevipiprant, a prostaglandin D2 receptor 2 antagonist, in patients with persistent eosinophilic asthma: a single-centre, randomised, double-blind, parallel-group, placebo- controlled trial  Sherif Gonem, PhD, Rachid Berair, MBChB, Amisha Singapuri, BSc, Ruth Hartley, MBChB, Marie F M Laurencin, BSc, Gerald Bacher, PhD, Björn Holzhauer, Dipl Math, Michelle Bourne, BSc, Vijay Mistry, BSc, Prof Ian D Pavord, DM, Adel H Mansur, PhD, Prof Andrew J Wardlaw, PhD, Prof Salman H Siddiqui, PhD, Richard A Kay, PhD, Prof Christopher E Brightling, PhD  The Lancet Respiratory Medicine  Volume 4, Issue 9, Pages 699-707 (September 2016) DOI: 10.1016/S2213-2600(16)30179-5 Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 1 Study design The Lancet Respiratory Medicine 2016 4, 699-707DOI: (10.1016/S2213-2600(16)30179-5) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 2 Trial profile Patients who completed the mid-treatment visit (27 in fevipiprant group and 30 in placebo group) were included in the primary analysis, with observations from the mid-treatment visit carried forward if data were not available at the post-treatment visit. ACQ-7=seven-point Asthma Control Questionnaire. The Lancet Respiratory Medicine 2016 4, 699-707DOI: (10.1016/S2213-2600(16)30179-5) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 3 Eosinophilic inflammation outcomes (A, B) Fold reduction in sputum and blood eosinophil counts at each study visit compared with baseline. Error bars represent 95% CIs. p values refer to differences between the treatment groups with respect to change from the baseline visit. (C, D) Lamina propria and epithelial eosinophil numbers. Data at baseline and the post-treatment visit for individual patients are shown as squares or circles linked by straight lines. Box and whisker plots show median with the 25th and 75th percentiles (boxes) and the 10th and 90th percentiles (whiskers). p values refer to differences between the treatment groups with respect to change from the baseline visit to the post-treatment visit. The Lancet Respiratory Medicine 2016 4, 699-707DOI: (10.1016/S2213-2600(16)30179-5) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 4 Changes (compared with baseline) in patient-reported and lung function outcomes Error bars represent SEM. p values refer to differences between the treatment groups with respect to change from the baseline visit. ACQ-7=seven-point Asthma Control Questionnaire. AQLQ(S)=standardised Asthma Quality of Life Questionnaire score. FEV1=forced expiratory volume in 1 s. The Lancet Respiratory Medicine 2016 4, 699-707DOI: (10.1016/S2213-2600(16)30179-5) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 5 Epithelial damage outcomes (A) Photomicrograph of a bronchial biopsy specimen showing the appearance of intact epithelium (I), partially denuded epithelium (P), and completely denuded epithelium (D); magnification 20×. (B–D) Proportion of intact epithelium, proportion of denuded epithelium, and thickness of intact epithelium at the baseline and post-treatment visits. Data at baseline and the post-treatment visit for individual patients are shown as squares or circles linked by straight lines. Error bars represent SEM. p values refer to differences between the treatment groups with respect to change from the baseline visit to the post-treatment visit. The Lancet Respiratory Medicine 2016 4, 699-707DOI: (10.1016/S2213-2600(16)30179-5) Copyright © 2016 Elsevier Ltd Terms and Conditions