Biomarkers and Surrogate Endpoints for Development of New Drug on Pulmonary Disease |
Seo, Jeong-Won
(College of Pharmacy, Chungnam University)
Lee, Byung-Yo (College of Pharmacy, Chungnam University) Chae, Jung-Woo (College of Pharmacy, Chungnam University) Son, Chu-Young (College of Pharmacy, Chungnam University) Kang, Won-Ku (College of Pharmacy, Catholic University of Daegu) Chae, Han-Jung (Departments of pharmacology, Chonbuk Natianal University Medical School) Kwon, Kwang-Il (College of Pharmacy, Chungnam University) |
1 | Liu, L., Jarjour, N., Busse, W. and Kelly, E. : Enhanced generation of helper T type 1 and 2 chemokines in allergen-induced aasthma. Am. J. Respir. Crit. Care. Med. 169, 1118 (2004). DOI ScienceOn |
2 | Baraldi, E., Carraro, S., Alinovi, R., Pesci, A., Ghiro, L., Bodini, A., Piacentini, G., Zacchello, F. and Zanconato, S. : Cysteinyl leukotrienes and 8-isoprostane in exhaled breath condensate of children with asthma exacerbations. Thorax 58, 505 (2003). DOI ScienceOn |
3 | Zeisberg, M. and Neilson, E. G. : Biomarkers for epithelialmesenchymal transitions. J. Clin. Invest. 119, 1429 (2009). DOI ScienceOn |
4 | Soehne, M., ten Wolde, M. and Bueller, H. R. : Biomarkers in pulmonary embolism. Current Opinion in Cardiology 19, 558 (2004). DOI ScienceOn |
5 | Kucher, N., Printzen, G., Doernhoefer, T., Windecker, S., Meier, B. and Hess, O. M. : Low pro-brain natriuretic peptide levels predict benign clinical outcome in acute pulmonary embolism. Circulation 107, 1576 (2003). DOI ScienceOn |
6 | Yariktas, M., Demirci, M., Aynali, G., Kaya, S. and Doner, F. : Relationship between Toxocara seropositivity and allergic rhinitis. Am. J. Rhinol. 21, 248 (2007). DOI |
7 | Nel, A. E., Strachan, A. F., Welke, H. E. and de Beer, F. C. : Acute phase response in bronchiectasis and bronchus carcinoma. Respiration 47, 196 (1985). DOI ScienceOn |
8 | Lezcano-Meza, D., Negrete-Garcia, M., Dante-Escobedo, M. and Teran, L. : The monocyte-derived chemokine is released in the bronchoalveolar lavage fluid of steady-state asthmatics. Allergy 58, 1125 (2003). DOI ScienceOn |
9 | Tzanakis, N., Chrysofakis, G., Tsoumakidou, M., Kyriakou, D., Tsiligianni, J., Bouros, D. and Siafakas, N. M. : Induced sputum CD8+ T-lymphocyte subpopulations in chronic obstructive pulmonary disease. Respir. Med. 98, 57 (2004). DOI ScienceOn |
10 | Montuschi, P. and Barnes, P. J. : Exhaled leukotrienes and prostaglandins in asthma. J. Allergy. Clin. Immunol. 109, 615 (2002). DOI ScienceOn |
11 | Pilette, C., Francis, J., Till, S. and Durham, S. : CCR4 ligands are up-regulated in the airways of atopic asthmatics after segmental allergen challenge. Eur. Respir. J. 23, 876 (2004). DOI ScienceOn |
12 | Itillie-Leblond, I., Hammad, H., Desurmont, S., Pugin, J., Wallaert, B., Tonnel, A. and Gosset, P. : CC chemokines and interleukin-5 in bronchial lavage fluid from patients with status asthmaticus. Potential implication in eosinophil recruitment. Am. J. Respir. Crit. Care. Med. 162, 586 (2000). |
13 | Tonnel, A., Gosset, P. and Tillie-Leblond, I. : Characteristics of the inflammatory response in bronchial lavage fluids from patients with status asthmaticus. Int. Arch. Allergy. Immunol. 124, 267 (2001). DOI ScienceOn |
14 | Cardinale, F., de Benedictis, F. M., Muggeo, V., Giordano, P., Loffredo, M. S., Iacoviello, G. and Armenio, L. : Exhaled nitric oxide, total serum IgE and allergic sensitization in childhood asthma and allergic rhinitis. Pediatr. Allergy Immunol. 16, 236 (2005). DOI ScienceOn |
15 | Kharitonov, S. A. ,Gonio, F., Kelly, C., Meah, S. and Barnes, P. J. : Reproducibility of exhaled nitric oxide measurements in healthy and asthmatic adults and children. Eur. Respir. J. 21, 433 (2003). DOI ScienceOn |
16 | Zeidler, M., Kleerup, E. and Tashkin, D. : Exhaled nitric oxide in the assessment of asthma. Curr. Opin. Pul. Med. 10, 31 (2003). |
17 | Gutierrez, V., Prieto, L., Torres, V., Trenor, R., Perez, C., Berto, J. and Marin, J. : Relationship between induced sputum cell counts and fluid-phase eosinophil cationic protein and clinical of physiologic profiles in mild asthma. Ann. Allergy. Asthma. Immunol. 82, 559 (1999). DOI ScienceOn |
18 | Lamkhioued, B., Renzi, P., Abi-Younes, S., Garcia- zepada, E., Allakhverdi, Z., Ghaffar, O., Rothenburg, M., Luster, A. and Hamid, Q. : Increased expression of eotaxin in bronchoalveolar lavage and airways of asthmatics contributes to the chemotaxis of eosinophils to the site of inflammation. J. Immunol. 159, 4593 (1997). |
19 | Boot, J., Panzer, P. and Diamant, Z. : A critical appraisal of methods used in early clinical development of novel drugs for the treatment of asthma. Pulm. Pharmacol. Ther. 20, 201 (2007). DOI ScienceOn |
20 | Wark, P. and Gibson, P. : Clinical usefulness of inflammatory markers in asthma. Am. J. Respir. Med. 2, 11 (2003). DOI ScienceOn |
21 | Pin, I., Freitag, A. and O'Byrne, P. : Changes in the cellular profile of induced sputum after allergen-induced asthmatic responses. Am. J. Respir. Crit. Care. Med. 145, 1265 (1992). DOI ScienceOn |
22 | Broekhuizen, R., Wouters, E. F. M., Creutzberg, E. C. and Schols, A. M. W. J. : Raised CRP levels mark metabolic and functional impairment in advanced COPD. Thorax 61, 17 (2006). |
23 | Vila, S., Miravitlles, M., Compos, F., de la Roza, C., Segura, R., Morell, F. and Vidal, R. : Importance of serum interleukin-6 as a mediator of systemic inflammation in patients with alpha-1 antitrypsin deficiency. Arch. Bronconeumol. 38, 263 (2002). DOI ScienceOn |
24 | Donaldson, G. C., Seemungal, T. A., Patel, I. S., Bhowmik, A., Wilkinson, T., Hurst, J. R., MacCallum, P. K. and Wedzicha, J. A. : Airway and systemic inflammation and decline in lung function in patients with COPD. Chest 128, 1995 (2005). DOI ScienceOn |
25 | Pinto-Plata, V. M., Muellerova, H., Toso, J. F., Feudjo-Tepie, M., Soriano, J. B., Vessey, R. S. and Celli, B. R. : C-reactive protein in patients with COPD, control smokers and non-smokers. Thorax 61, 23 (2006). |
26 | Yamamoto, C., Yoneda, T., Yoshikawa, M., Fu, A., Tokuyama, T., Tsukaguchik, K. and Narita, N. : Airway inflammation in COPD assessed by sputum levels of interleukin-8. Chest 112, 505 (1997). DOI ScienceOn |
27 | Montuschi, P., Collins, J. V., Ciabattoni, G., Lazzeri, N., Corradi, M., Kharitonov, S. A. and Barnes, P. J. : Exhaled 8-isoprostane an in vivo biomarker of lung oxidative stress in patients with COPD and healthy smokers. Am. J. Respir. Crit. Care. Med. 162, 1175 (2000). DOI ScienceOn |
28 | Carpagnano, G. E., Resta, O., Foschino-Barnaro, M. P., Spanevello, A., Stefano, A., Di Gioia, G., Serviddio, G. and Gramiccioni, E. : Exhaled interleukin-6 and 8-isoprostane in chronic obstructive pulmonary disease: effect of carbocysteine lysine salt monohydrate (SCMC-Lys). Eur. J. Pharmacol. 505, 169 (2004). DOI ScienceOn |
29 | Biernacki, W. A., Kharitonov, S. A. and Barnes, P. J. : Increased leukotriene B4 and 8-isoprostane in exhaled breath condensate of patients with exacerbations of COPD. Thorax 58, 294 (2003). DOI ScienceOn |
30 | Keatings, V. M., Collins, P. D., Scott, D. M. and Barnes, P. J. : Differences in interleukin-8 and tumor necrosis factor-alpha in induced sputum from patients with chronic obstructive pulmonary disease or asthma. Am. J. Respir. Crit. Care. Med. 153, 530 (1996). DOI ScienceOn |
31 | Kharitonov, S. A. and Barnes, P. J. : Biomarkers of some pulmonary diseases in exhaled breath. Biomarkers, 7, 1 (2002). DOI ScienceOn |
32 | ATS/ERS Rcommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am. J. Respir. Crit. Care. Med. 171, 912 (2005). DOI ScienceOn |
33 | de Raucourt, E., Meyer, G., Landais, P., Gouaref, Z., Morinet, P., Monge, F., Sors, H. and Fischer, A. M. : Markers of hemostatic system activation in pulmonary embolism. Changes during and after cessation of anticoagulant treatment. Blood Coagul Fibrinolysis 11(3), 249 (2000). |
34 | Frank, R. and Hargreaves, R. : Clinical biomarkers in drug discovery and development. Nat. Rev. Drug. Discov. 2, 566 (2003). DOI ScienceOn |
35 | Yamabuki, T., Takano, A., Hayama, S., Ishikawa, N., Kato, T., Miyamoto, M., Ito, T., Ito, H., Miyagi, Y., Nakayama, H., Fujita, M., Hosokawa, M., Tsuchiya, E., Kohno, N., Kondo, S., Nakamura, Y. and Daigo, Y. : Dikkopf-1 as a novel serologic and prognostic biomarker for lung and esophageal carcinomas. Cancer. Res. 67(6), 2517 (2007). DOI ScienceOn |
36 | Sekine, I., Tamura, T., Kunitoh, H., Kubota, K., Shinkai, T., Kamiya, Y. and Saijo, N. : Progressive disease rate as a surrogate endpoint of phase II trials for non-small-cell lung cancer. Annals of Oncology 10, 731 (1999). DOI ScienceOn |
37 | Kline, J. A., Hernandez-Nino, J., Rose, G., Norton, H. J. and Camargo, C. A. Jr. : Surrogate markers for adverse outcomes in normotensive patients with pulmonary embolism. Crit. Care. Med. 34(11), 2773 (2006). DOI ScienceOn |
38 | Jaffer, F. A., Libby, P. and Weissleder, R. : Molecular imaging of cardiovascular disease. Circulation 116, 1052 (2007). DOI ScienceOn |
39 | Rasp, G. and Hochstarasser, K. : Tryptase in nasal fluid is a useful marker of allergic rhinitis. Allergy 48(2), 72 (1993). DOI ScienceOn |
40 | Fang, S.-Y. and Shen, C.-L. : Neuropeptide innervations and neuroendocrine cells in allergic rhinitis and chronic hypertrophic rhinitis. Clin. Exper. Allergy 28, 228 (1998). DOI ScienceOn |
41 | Francis, J. N., Lloyd, C. M., Sabroe, I., Durham, S. R. and Till, S. J. : T lymphocytes expressing CCR3 are increased in allergic rhinitis compared with non-allergic controls and following allergen immunotherapy. Allergy 62, 59 (2007). DOI ScienceOn |
42 | Henriksen, A. H., Sue-Chu, M., Lingaas Holmen, T., Langhammer, A. and Bjermer, L. : Exhaled and nasal NO level in allergic rhinitis: relation to sensitization, pollen season and bronchial hyperresponsiveness. Eur. Respir. J. 13, 301 (1999). DOI ScienceOn |
43 | Santamaria, F., Montella, S., Camera, L., Palumbo, C., Greco, L. and Boner, A. L. : Lung structure abnormalities, but normal lung function in pediatric bronchiectasis. Chest 130, 480 (2006). DOI ScienceOn |
44 | Matsuzaki, K. and Okazaki, K. : Transforming growth factorbeta during carcinogenesis: the shift from epithelial to mesenchymal signaling. J. Gastroenterol. 41, 295 (2006). DOI ScienceOn |
45 | Kinnula, V. L. and Myllarniemi, M. : Oxidant-antioxidant imbalance as a potential contributor to the progression of human pulmonary fibrosis. Antioxid Redox Sign 10(4), 727 (2008). DOI ScienceOn |
46 | Harrison, A. and Amundson, S. : Evaluation and management of the acutely dyspneic patient: the role of biomarkers. Am. J. Emerg. Med. 23, 371 (2005). DOI ScienceOn |
47 | Strieter, R. M., Starko, K. M., Enelow, R. I., Noth, I., Valentine, V. G. and the other members of the Idiopathic Pulmonary Fibrosis Biomarkers Study Group : Effects of interferon-gamma 1b on biomarker expression in patients with idiopa ahic pulmonary fibrosis. Am. J. Respir. Crit. Care. Med. 170, 133 (2004). DOI ScienceOn |
48 | Kucher, N. and Goldhaber, S. Z. : Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism. Circulation 108, 2191 (2003). DOI ScienceOn |
49 | Torbicki, A., Pruszczyk, P. and Kurzyna, M. : Pulmonary embolism: role of echocardiography and of biological markers. Ital. Heart. J. 6(10), 805 (2005). |
50 | Kucher, N. and Goldhaber, S. Z. : Risk stratification of acute pulmonary embolism. Semin Thromb Hemost 32, 838 (2006). DOI ScienceOn |
51 | Kucher, N., Printzen, G. and Goldhaber, S. Z. : Prognostic role of brain natriuretic peptide in acute pulmonary embolism. Circulation 107, 2545 (2003). DOI ScienceOn |
52 | Lazarus, R., Raby, B. A., Lange, C., Silverman, E. K., Kwiatkowski, D. J., Vercelli, D., Klimecki, W. J., Martinez, F. E. and Weiss, S. T. : TOLL-like receptor 10 genetic variation is associated with asthma in two independent samples. Am. J. Respir. Crit. Care. Med. 170, 594 (2004). DOI ScienceOn |
53 | Brody, A. S., Tiddens, H. A. W. M., Gastile, R. G., Coxson, H. O., de Jong, P. A., Goldin, J., Huda, W., Long, F. R., McNitt- Gray, M., Rock, M., Robinson, T. E. and Sagel, S. G. for the CT Scanning in Cystic Fibrosis Special Interest Group : Computed tomography in the evaluation of cystic fibrosis lung disease. Am. J. Respir. Crit. Care. Med. 172, 1246 (2005). DOI ScienceOn |
54 | Sagel, S. D., Chmiel, J. F. and Konstan, M. W. : Sputum biomarkers of inflammation in cystic fibrosis lung disease. Proc. Am. Thorac. Soc. 4, 406 (2007). DOI ScienceOn |
55 | Kerem, E., Reisman, J., Corey, M., Canny, G. J. and Levison, H. : Prediction of mortality in patients with cystic fibrosis. New Engl. J. Med. 326, 1187 (1992). DOI ScienceOn |
56 | Brody, A. S., Molina, P. L., Klein, J. S., Rothman, B. S., Ramagopal, M. and Swartz, D. R. : High-resolution computed tomography of the chest in children with cystic fibrosis: support for use as an outcome surrogate. Pediatr. Radiol. 29, 731 (1999). DOI ScienceOn |
57 | Suraokar, M. B., Lin, H., He, D., Llansa, N., Mendoza, G., Woods, D., Prudkin, L., Lee, J. J., Wistuba, I. I. and Tsao, A. S. : High expression of epithelial-mesenchymal transition (EMT) markers in malignant mesothelioma and possible therapeutic intervention using an N-cadherin antagonist. 2008 ASCO Annual Meeting abstr 8067 (2008). |
58 | Kalayci, O., Sonna, L., Woodruff, P., Camargo, C., Luster, A. and Lilly, C. : Monocyte chemotactic protein-4 (MCP-4; CCL-13): A biomarker of asthma. J. Asthma. 41, 27 (2004). DOI ScienceOn |
59 | Tateno, H., Nakamura, H., Minematsu, N., Nakajima, T., Takahashi, S., Nakamura, M., Fukunaga, K., Asano, K., Lilly, C. and Yamaguchi, K. : Plasma eotaxin level and severity of asthma treated with corticosteroid. Respir. Med. 98, 782 (2004). DOI ScienceOn |
60 | Leung, T., Wong, G., Ko, F., Lam, C. and Fok, T. : Increased macrophage-derived chemokine in exhaled breath condensate and plasma from children with asthma. Clin. Exp. Allergy 34, 786 (2004). DOI ScienceOn |
61 | Turner, S. : Exhaled nitric oxide in the diagnosis and management of asthma. Curr. Opin. Allergy Clin. Immunol. 8, 70 (2008). DOI ScienceOn |
62 | Abdel-Rahman, A., El-Sahrigy, S. and Bakr, S. : A comparative study of two angiogenic facters: vascular endothelial growth factor and angiogenin in induced sputum from asthmatic children in acute attack. Chest 129, 266 (2006). DOI ScienceOn |
63 | Corradi, M., Montuschi, P., Donnelly, L. E., Pesci, A., Kharitonov, S. A. and Barnes, P. J. : Increased nitrosothiols in exhaled breath condensate in inflammatory airway disease. Am. J. Respir. Crit. Care. Med. 163, 854 (2001). DOI ScienceOn |
64 | Gan, W. Q., Man, S. F., Senthilselvan, A. and Sin, D. D. : Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a metaanalysis. Thorax 59, 574 (2004). DOI ScienceOn |
65 | Malo, O., Sauleda, J., Busquets, X., Miralles, C., Agusti, A. G. and Noguera, A. : Systemic inflammation during exacerbations of chronic obstructive pulmonary disease. Arch. Bronconeumol. 38, 172 (2002). DOI ScienceOn |
66 | Corradi, M., Rubistein, I., Andreoli, R., Manini, P., Caglieri, A., Poli, D., Alinovi, R. and Mutti, A. : Aldehydes in exhaled breath condensate of patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 167, 1380 (2003). DOI ScienceOn |
67 | Kostikas, K., Papatheodorou, G., Ganas, K., Psathakis, K., Panagou, P. and Loukides, S. : pH in expired breath condensate of patients with inflammatory airway disease. Am. J. Respir. Crit. Care. Med. 165, 1364 (2002). |
68 | Borrill, Z., Starkey, C., Vestbo, J. and Singh, D. : Reproducibility of exhaled breath condensate pH in chronic obstructive pulmonary disease. Eur. Respir. J. 25, 269 (2005). DOI ScienceOn |
69 | Kostikas, K., Gaga, M., Papatheodorou, G., Karamanis, T., Orphanidou, D. and Loukides, S. : Leukotriene B4 in exhaled breath condensate and sputum supernatant in patients with COPD and asthma. Chest 127, 1553 (2005). DOI ScienceOn |
70 | Saetta, M., Turato, G., Maestrelli, P., Mapp, C. E. and Fabbri, L. M. : Cellular and structural bases of chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 163, 1304 (2001). DOI ScienceOn |
71 | Snell, N. and Newbold, P. : The clinical utility of biomarkers in asthma and COPD. Curr. Opin. Pharmacol. 8, 222 (2008). DOI ScienceOn |
72 | O'Shaughnessy, T. C., Ansari, T. W., Barnes, N. C. and Jeffery, P. K. : Inflammation in bronchial biopsies of subjects with chronic bronchitis: inverse relationship of CD8+ T lymphocytes with FEV1. Am. J. Respir. Crit. Care. Med. 155, 852 (1997). DOI ScienceOn |
73 | Colburn, W. A. : Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development. J. Clin. Pharmacol. 40, 1419 (2000). |
74 | Danhof, M., Alvan, G., Dahl, S. G., Kuhlmann, J. and Paintaud, G. : Mechanism-based pharmacokinetic-pharmacodynamic modeling-a new classification of biomarkers. Pharm. Res. 22(9), 1432 (2005). DOI ScienceOn |
75 | Lesko, L. J. and Atkinson, A. J. : Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies. Annu. Rev. Pharmacol. 41, 347 (2001). DOI ScienceOn |
76 | Wagner, J. A. : Biomarker validation and qualification: Fitness for use. Biomarker World Congress (2007). |
77 | Rolan, P., Atkinson, A. J. and Lesko, L. J. : Use of biomarkers from drug discovery through clinical practice: Report of the ninth European federation of pharmaceutical sciences conference on optimizing drug development. Clin. Pharmacol. Ther. 73(4), 284 (2003). DOI ScienceOn |
78 | Rolan, P. : The contribution of clinical pharmacology surrogates and models to drug development-a critical appraisal. Brit. J. Clin. Pharmacol. 44, 219 (1997). |
79 | 성수현, 윤휘열, 백인환, 강원구, 장정윤, 서경원, 권광일 : 당뇨 병 및 골다공증 치료제의 효율적인 신약개발을 위한 생체표지자 및 대리 결과 변수의 역할 및 활용. 약학회지 52(5), 314 (2008). 과학기술학회마을 |
80 | Colburn, W. A. : Biomarkers in drug discovery and development: From target identification through drug marketing. J. Clin. Pharmacol. 43, 329 (2003). DOI ScienceOn |
81 | Lee, J. W., Devanarayan, V., Barrett, Y. C., Weiner, R., Allinson, J., Fountain, S., Keller, S., Weinryb, I., Green, M., Duan, L., Rogers, J. A., Millham, R., O'Brien, P. J., Sailstad, J., Khan, M., Ray, C. and Wagner, J. A. : Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312 (2006). DOI ScienceOn |
82 | Lee, J. W., Smith, W. C., Nordblom, G. D. and Bowsher, R. R. : Validation of assays for the bioanalysis of novel biomarkers: Practical recommendations for clinical investigation of new drug entities. Biomarkers in Clinical Drug Development 132, 119 (2003). |
83 | Vestbo, J., Anderson, W., Coxson, H. O., Crim, C., Dawber, F., Edwards, L., Hagan, G., Knobil, K., Lomas, D. A., MacNee, W., Silverman, E. K. and Tal-Singer, R. : Evaluation of COPD longitudinally to identify predictive surrogate end-points (ECLIPSE). Eur. Respir. J. 31, 869 (2008) DOI ScienceOn |
84 | Brightling, C. E., McKenna, S., Hargadon, B., Birring, S., Green, R., Siva, R., Berry, M., Parker, D., Monteiro, W., Pavord, I. D. and Bradding, P. : Sputum eosinophilia and the short term response to inhaled mometasone in chronic obstructive pulmonary disease. Thorax 60, 193 (2005). DOI ScienceOn |
85 | Revision of Committee: Critical path opportunities reports. FDA (2006): Online service. |
86 | Stanski, D. R. : Model-based drug development: A critical path opportunity. FDA (2006). |
87 | Revision Committee: Post-genomic biomarker. Bioview 12(3),(2004). |
88 | 이철주 : 바이오마커 연구개발 동향 한국생화학분자생물학회 (KSBMB) Webzine 2008년 5월호 http://www.biochem.or.kr/sub/popup_letter.php?CatNo=642. |
89 | Twaddell, S. : Surrogate outcome markers in research and clinical practice. Aust. Prescr. 32, 47 (2009) DOI |
90 | Montuschi, P., Kharitonov, S. A. and Barnes, P. J. : Exhaled carbon monoxide and nitric oxide in COPD. Chest 120, 496 (2001). DOI ScienceOn |
91 | Panzner, P., Lafitte, J. J., Tsicopoulos, A., Hamid, Q. and Tulic, M. K. : Marked up-regulation of T lymphocytes and expression of interleukin-9 in bronchial biopsies from patients with chronic bronchitis with obstruction. Chest 124, 1909 (2003). DOI ScienceOn |
92 | Aaron, S. E., Angel, J. B., Lunau, M., Wright, K., Fex, C., Le Saux, N. and Dales, R. E. : Granulocyte inflammatory markers and airway infection during acute exacerbation of chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 163, 349 (2001). DOI ScienceOn |
93 | Kalenderian, R., Raju, L., Roth, W., Schwartz, L. B., Gruber, B. and Janoff, A. : Elevated histamine and tryptase levels in smokers' bronchoalveolar lavage fluid. Do lung mast cells contribute to smokers' emphysema? Chest 94, 119 (1988). DOI ScienceOn |
94 | Pesci, A., Balbi, B., Majori, M., Cacciani, G., Bertacco, S., Alciato, P. and Donner, C. F. : Inflammatory cells and mediators in bronchial lavage of patients with chronic obstructive pulmonary disease. Eur. Respir. J. 12, 380 (1998). DOI ScienceOn |
95 | Brightling, C. E., Monteiro, W., Ward, R., Parker, D., Monrgan, M., Wardlaw, A. J. and Pavord, I. D. : Sputum eosinophilia and short-term response to proednisolone in chronic obstructive pulmonary disease: a randomised controlled trial. Lancet, 356, 1480 (2000). DOI ScienceOn |
96 | Saetta, M., Di Stefano, A., Maestrelli, P., Ferraresso, A., Drigo, R., Potena, A., Ciaccia, A. and Fabbri, L. M. : Activated Tlymphocytes and macrophages in bronchial mucosa of subjects with chronic bronchitis. Am. Rev. Respir. Dis. 147, 301 (1993). DOI ScienceOn |
97 | Russell, R. E., Culpitt, S. V., De Matos, C., Donnelly, L., Smith, M., Wiggins, J. and Barnes, P. J. : Release and activity of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase- 1 by alveolar macrophages from patients with chronic obstructive pulmonary disease. Am. J. Respir. Cell. Mol. Biol. 26, 602 (2002). DOI ScienceOn |
98 | Grumelli, S., Corry, D. B., Song, L. Z., Song, L., Green, L., Huh, J., Hacken, J., Espada, R., Bag, R., Lewis, D. E. and Kheradmand, F. : An immune basis for lung parenchymal destruction in chronic obstructive pulmonary disease and emphysema. PLoS Med. 1, e8 (2004). DOI ScienceOn |
99 | Saetta, M., Mariani, M., Panina-Bordignon, P., Turato, G., Buonsanti, C., Baraldo, S., Bellettato, C. M., Papi, A., Corbetta, L., Zuin, R., Sinigaglia, F. and Fabbri, L. M. : Increased expression of the chemokine receptor CXCR3 and its ligand CXCL10 in peripheral airways of smokers with chronic onstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 165, 1404 (2002). DOI ScienceOn |
100 | Culpitt, S. V., Rogers, D. F., Shah, P., De Matos, C., Russell, R. E. K., Donnelly, L. E. and Barnes, P. J. : Impaired inhibition by dexamethasone of cytokine release by alveolar macrophages from patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 167, 24 (2003). DOI ScienceOn |
101 | Cazzola, M., MacNee, W., Martinez, F. J., Rabe, K. F., Franciosi, L. G., Barnes, P. J., Brusasco, V., Burge, P. S., Calverley, P. M. A., Celli, B. R., Jones, P. W., Mahler, D. A., Make, B., Miravitlles, M., Page, C. P., Palange, P., Parr, D., Pistolesi, M., Rennard, S. I., Rutten-van Moelken, M. P., Stockley, R., Sullivan, S. D., Wedzicha, J. A. and Wouters, E. F. on behalf of the American Thoracic Society/European Respiratory Society Task Force on outcomes of COPD : Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur. Respir. J. 31, 416 (2008). DOI ScienceOn |
102 | Jatakanon, A., Uasuf, C., Maziak, W., Lim, S., Chung, K. and Barnes, P. : Neutrophilic inflammation in severe persistent asthma. Am. J. Respir. Crit. Care. Med. 160, 1532 (1999). DOI ScienceOn |
103 | Di Franco, A., Bartoli, M, Carnevali, S., Cianchetti, S., Bacci, E., Dente, F., Giannini, D., Taccola, M., Vagaggini, B. and Paggiaro, P. : Analysis of sputum cell counts during spontaneous moderate exacerbations of asthma in comparison to the stable phase. J. Asthma. 20, 155 (2003). |
104 | Gibson, P., Simpson, J., Hankin, R., Powell, H. and Henry, R. : Relationship between induced sputum eosinophils and the clinical pattern of childhood asthma. Thorax 58, 116 (2003) DOI ScienceOn |
105 | Obase, Y., Shimoda, T., Mitsuta, K., Matsuo, N., Matsuse, H. and Kohno, S. : Correlation between airway hyperresponsiveness and airway inflammation in a young adult population: eosinophil, ECP, and cytokine levels in induced sputum. Ann. Allergy. Asthma. Immunol. 86, 304 (2001). DOI ScienceOn |
106 | Park, S., Kim, J., Chang, H., Park, S., Lee, Y., Park, J., Chun, I., Lee, J. and Park, C. : Association of interleukin-5 and eotaxin with acute exacerbation of asthma. Int. Arch. Allergy. Immunol. 131, 283 (2003). DOI ScienceOn |
107 | Nguyen, L. T., Bedu, M., Caillaud, D., Beaufrere, B., Beaujon, G., Vasson, M.-P., Coudert, J. and Ritz, P. : Increased resting energy expenditure is related to plasma TNF-alpha concentration in stable COPD patients. Clin. Nutrit. 18, 269 (1999). DOI ScienceOn |
108 | in't Veen, J., Smits, H., Hiemstra, P., Zwinderman, A., Sterk, P. and Bel, E. : Lung function and sputum characteristics of patients with severe asthma during an induced exacerbation by double-blind steroid withdrawal. Am. J. Respir. Crit. Care. Med. 160, 93 (1999). DOI ScienceOn |
109 | Hurst, J. R., Perera, W. R., Wilkinson, T. M., Donaldson, G. C. and Wedzicha, J. A. : Systemic and upper and lower airway inflammation at exacerbation of chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 173, 71 (2006). DOI ScienceOn |
110 | Vernooy, J. H., Kucukaycan, M., Jacobs, J. A., Chavannes, N. H., Buurman, W. A., Dentener, M. A. and Wouters, E. F. : Local and systemic inflammation in patients with chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 166, 1218 (2002). DOI ScienceOn |
111 | Dekhuijzen, P. N., Aben, K. K., Dekker, I., Aarts, L., Wielders, P., van Herwaarden, C. and Bast, A. : Increased exhalation of hydrogen peroxide in patients with stable and unstable chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 154, 813 (1996). DOI ScienceOn |
112 | Bucchioni, E., Kharitonov, S. A., Allegra, L. and Barnes, P. J. : High levels of interleukin-6 in the exhaled breath condensate of patients with COPD. Respir. Med. 97, 1299 (2003). DOI ScienceOn |
113 | Paredi, P., Kharitonov, S. A., Leak, D., Ward, S., Cramer, D. and Barnes, P. J. : Exhaled ethane, a marker of lipid peroxidation, is elevated in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med. 162, 369 (2000). DOI ScienceOn |
114 | Montuschi, P. and Barnes, P. J. : Analysis of exhaled breath condensate for monitoring airway inflammation. Trends. Pharmacol. Sci. 23, 232 (2002). DOI ScienceOn |
115 | Kostikas, K., Papatheodorou, G., Psathakis, K., Panagou, P. and Loukides, S. : Oxidative stress in expired breath condensate of patients with COPD. Chest 124, 1373 (2003). DOI ScienceOn |
116 | Woosley, R. L. and Cossman, J. : Drug development and the FDA's critical path initiative. Clin. Pharmacol. Ther. 81(1), 129 (2007). DOI ScienceOn |
117 | Revision of Committee : Challenge and Opportunity on the critical path to new medical product. FDA (2004). |
118 | Biomarkers Definition Working Group (BDWG) : Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69(3), 89 (2001). DOI ScienceOn |