Efficacy of the oral chemoattractant receptor homologous molecule on T H2 cells antagonist BI 671800 in patients with seasonal allergic rhinitis

Journal of Allergy and Clinical Immunology

Volumn 133, Issue 2, 2014, Pages

  Krug, Norbert ^a   Gupta, Abhya ^b   Badorrek, Philipp ^a   Koenen, Ruediger ^b   Mueller, Meike ^a   Pivovarova, Anna ^b   Hilbert, James ^c   Wetzel, Kristiane ^b   Hohlfeld, Jens M ^a   Wood, Chester ^c  

^a FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

^b BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^c BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

BI 671800; environmental challenge chamber; inflammation; seasonal allergic rhinitis

Indexed keywords

ANTIALLERGIC AGENT; ANTIHISTAMINIC AGENT; BI 671800; BIOLOGICAL MARKER; CHEMOATTRACTANT RECEPTOR HOMOLOGOUS MOLECULE ON TH2 CELLS; CYTOKINE; EOTAXIN; FLUTICASONE PROPIONATE; INTERLEUKIN 13; INTERLEUKIN 4; INTERLEUKIN 5; LEUKOTRIENE RECEPTOR BLOCKING AGENT; MONTELUKAST; NOSE SPRAY; PLACEBO; PROSTAGLANDIN D2; PROSTAGLANDIN RECEPTOR; STEROID; UNCLASSIFIED DRUG;

ADULT; AGED; ALLERGIC RHINITIS; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DACTYLIS GLOMERATA; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENVIRONMENTAL CHALLENGE CHAMBER; ENVIRONMENTAL EXPOSURE; EOSINOPHIL COUNT; EPISTAXIS; FEMALE; GENERAL DEVICE; HAY FEVER; HEADACHE; HUMAN; INFLAMMATION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NASAL PRURITUS; NOSE OBSTRUCTION; PHASE 2 CLINICAL TRIAL; POLLEN; PRICK TEST; PRIORITY JOURNAL; PROVOCATION TEST; RANDOMIZED CONTROLLED TRIAL; RECEPTOR BLOCKING; RHINORRHEA; SKIN TEST; SNEEZING; SYMPTOM; TH2 CELL; TREATMENT OUTCOME;

ADVERSE EVENT; AE; ALLERGIC RHINITIS; AR; AREA UNDER THE CURVE; AUC; BI 671800; CHEMOATTRACTANT RECEPTOR HOMOLOGOUS MOLECULE ON T(H)2 CELLS; CRTH2; ECC; ENVIRONMENTAL CHALLENGE CHAMBER; EOSINOPHIL SHAPE CHANGE; ESC; FLUTICASONE PROPIONATE; FORWARD SCATTER; FP; FSC; INFLAMMATION; MIXED-MODEL REPEATED MEASURE; MMRM; PGD(2); PROSTAGLANDIN D(2); SAR; SEASONAL ALLERGIC RHINITIS; TNSS; TOTAL NASAL SYMPTOM SCORE;

ADULT; ALLERGENS; ANTI-ALLERGIC AGENTS; CROSS-OVER STUDIES; CYTOKINES; DOUBLE-BLIND METHOD; EOSINOPHILS; FEMALE; HUMANS; LEUKOCYTE COUNT; MALE; MIDDLE AGED; NASAL MUCOSA; POACEAE; POLLEN; RECEPTORS, IMMUNOLOGIC; RECEPTORS, PROSTAGLANDIN; RHINITIS, ALLERGIC, SEASONAL; TREATMENT OUTCOME;

EID: 84895056732     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2013.10.013     Document Type: Article

References (29)

1. B. Sin, and A. Togias Pathophysiology of allergic and nonallergic rhinitis Proc Am Thorac Soc 8 2011 106 114
2. S.N. Mandhane, J.H. Shah, and R. Thennati Allergic rhinitis: an update on disease, present treatments and future prospects Int Immunopharmacol 11 2011 1646 1662
3. E. Kostenis, and T. Ulven Emerging roles of DP and CRTH2 in allergic inflammation Trends Mol Med 12 2006 148 158
4. R. Pettipher, T.T. Hansel, and R. Armer Antagonism of the prostaglandin D2 receptors DP1 and CRTH2 as an approach to treat allergic diseases Nat Rev Drug Discov 6 2007 313 325
5. J.J. Murray, A.B. Tonnel, A.R. Brash, L.J. Roberts, P. Gosset, and R. Workman et al. Release of prostaglandin D2 into human airways during acute antigen challenge N Engl J Med 315 1986 800 804
6. W.J. Doyle, S. Boehm, and D.P. Skoner Physiologic responses to intranasal dose-response challenges with histamine, methacholine, bradykinin, and prostaglandin in adult volunteers with and without nasal allergy J Allergy Clin Immunol 86 1990 924 935
7. R. Pettipher, and M. Whittaker Update on the development of antagonists of chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTH2). From lead optimization to clinical proof-of-concept in asthma and allergic rhinitis J Med Chem 55 2012 2915 2931
8. L. Xue, A. Barrow, and R. Pettipher Novel function of CRTH2 in preventing apoptosis of human Th2 cells through activation of the phosphatidylinositol 3-kinase pathway J Immunol 182 2009 7580 7586
9. B.A. Stearns, C. Baccei, G. Bain, A. Broadhead, R.C. Clark, and H. Coate et al. Novel tricyclic antagonists of the prostaglandin D2 receptor DP2 with efficacy in a murine model of allergic rhinitis Bioorg Med Chem Lett 19 2009 4647 4651
10. N.W. Lukacs, A.A. Berlin, K. Franz-Bacon, R. Sasik, L.J. Sprague, and T.W. Ly et al. CRTH2 antagonism significantly ameliorates airway hyperreactivity and downregulates inflammation-induced genes in a mouse model of airway inflammation Am J Physiol Lung Cell Mol Physiol 295 2008 L767 L779
11. M. Okano, T. Fujiwara, Y. Sugata, D. Gotoh, Y. Masaoka, and M. Sogo et al. Presence and characterization of prostaglandin D2-related molecules in nasal mucosa of patients with allergic rhinitis Am J Rhinol 20 2006 342 348
12. F. Nantel, C. Fong, S. Lamontagne, D.H. Wright, A. Giaid, and M. Desrosiers et al. Expression of prostaglandin D synthase and the prostaglandin D2 receptors DP and CRTH2 in human nasal mucosa Prostaglandins Other Lipid Mediat 73 2004 87 101
13. L. Cameron, M. Depner, M. Kormann, N. Klopp, T. Illig, and M.E. von et al. Genetic variation in CRTh2 influences development of allergic phenotypes Allergy 64 2009 1478 1485
14. N. Barnes, I. Pavord, A. Chuchalin, J. Bell, M. Hunter, and T. Lewis et al. A randomized, double-blind, placebo-controlled study of the CRTH2 antagonist OC000459 in moderate persistent asthma Clin Exp Allergy 42 2012 38 48
15. F. Horak, P. Zieglmayer, R. Zieglmayer, P. Lemell, L.P. Collins, and M.G. Hunter et al. The CRTH2 antagonist OC000459 reduces nasal and ocular symptoms in allergic subjects exposed to grass pollen, a randomised, placebo-controlled, double-blind trial Allergy 67 2012 1572 1579
16. N. Krug, J.M. Hohlfeld, M. Larbig, A. Buckendahl, P. Badorrek, and H. Geldmacher et al. Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis Clin Exp Allergy 33 2003 1667 1674
17. G.C. Nicholson, H.H. Kariyawasam, A.J. Tan, J.M. Hohlfeld, D. Quinn, and C. Walker et al. The effects of an anti-IL-13 mAb on cytokine levels and nasal symptoms following nasal allergen challenge J Allergy Clin Immunol 128 2011 800 807
18. P. Badorrek, M. Dick, A. Schauerte, H. Hecker, R. Murdoch, and B. Luettig et al. A combination of cetirizine and pseudoephedrine has therapeutic benefits when compared to single drug treatment in allergic rhinitis Int J Clin Pharmacol Ther 47 2009 71 77
19. P. Badorrek, M. Dick, H. Hecker, F. Schaumann, A.R. Sousa, and R. Murdoch et al. Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season Ann Allergy Asthma Immunol 106 2011 336 341
20. J.M. Hohlfeld, T. Holland-Letz, M. Larbig, M. Lavae-Mokhtari, E. Wierenga, and M. Kapsenberg et al. Diagnostic value of outcome measures following allergen exposure in an environmental challenge chamber compared with natural conditions Clin Exp Allergy 40 2010 998 1006
21. E.O. Meltzer, H.A. Orgel, E.A. Bronsky, C.T. Furukawa, J. Grossman, and C.F. LaForce et al. A dose-ranging study of fluticasone propionate aqueous nasal spray for seasonal allergic rhinitis assessed by symptoms, rhinomanometry, and nasal cytology J Allergy Clin Immunol 86 1990 221 230
22. P.H. Ratner, M.A. Wingertzahn, J.H. van Bavel, F. Hampel, P.F. Darken, and S. Hellbardt et al. Effectiveness of ciclesonide nasal spray in the treatment of seasonal allergic rhinitis Ann Allergy Asthma Immunol 97 2006 657 663
23. R. Sutherland, K. Tetzlaff, C. Nivens, A. Tsukayama, R.M. Guerreros, and E. Bateman et al. Efficacy and safety of BI 671800, an oral CRTH2 antagonist in controller naïve patients with poorly-controlled asthma Eur Respir J 40 Suppl 56 2012 546S
24. I. Hall, M. Sarno, B. Disse, S. Atis, E. Bateman, and H. Finnigan et al. Efficacy and safety of BI 671800, an oral CRTH2 antagonist, as add on therapy in poorly controlled asthma patients prescribed an inhaled corticosteroid Eur Respir J 40 Suppl 56 2012 312S
25. D. Singh, P. Cadden, M. Hunter, C.L. Pearce, M. Perkins, and R. Pettipher et al. Inhibition of the asthmatic allergen challenge response by the CRTH2 antagonist OC000459 Eur Respir J 41 2013 46 52
26. E.M. Erin, B.R. Leaker, A.S. Zacharasiewicz, L.A. Higgins, T.J. Williams, and M.J. Boyce et al. Single dose topical corticosteroid inhibits IL-5 and IL-13 in nasal lavage following grass pollen challenge Allergy 60 2005 1524 1529
27. C.D. Serrano, A. Valero, J. Bartra, J. Roca-Ferrer, R. Munoz-Cano, and J. Sanchez-Lopez et al. Nasal and bronchial inflammation after nasal allergen challenge: assessment using noninvasive methods J Investig Allergol Clin Immunol 22 2012 351 356
28. C. Bachert, M. van Kempen, and P. Van Cauwenberge Regulation of proinflammatory cytokines in seasonal allergic rhinitis Int Arch Allergy Immunol 118 1999 375 379
29. C.M. Lloyd, and E.M. Hessel Functions of T cells in asthma: more than just T(H)2 cells Nat Rev Immunol 10 2010 838 848