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Volumn 20, Issue 5, 2014, Pages 463-471

IPF clinical trial design and endpoints

Author keywords

clinical trials as topic; pulmonary fibrosis; research design; respiratory function tests

Indexed keywords

BIOLOGICAL MARKER;

EID: 84906046346     PISSN: 10705287     EISSN: 15316971     Source Type: Journal    
DOI: 10.1097/MCP.0000000000000091     Document Type: Review
Times cited : (54)

References (48)
  • 1
    • 75949130829 scopus 로고    scopus 로고
    • Strategies for treating idiopathic pulmonary fibrosis
    • du Bois RM. Strategies for treating idiopathic pulmonary fibrosis. Nat Rev Drug Discov 2010; 9:129-140.
    • (2010) Nat Rev Drug Discov , vol.9 , pp. 129-140
    • Du Bois, R.M.1
  • 2
    • 84861382039 scopus 로고    scopus 로고
    • Idiopathic pulmonary fibrosis: Clinically meaningful primary endpoints in phase 3 clinical trials
    • Raghu G, Collard HR, Anstrom KJ, et al. Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. Am J Respir Crit Care Med 2012; 185:1044-1048.
    • (2012) Am J Respir Crit Care Med , vol.185 , pp. 1044-1048
    • Raghu, G.1    Collard, H.R.2    Anstrom, K.J.3
  • 3
    • 84865112235 scopus 로고    scopus 로고
    • Idiopathic pulmonary fibrosis: Lung function is a clinically meaningful endpoint for phase 3 trials
    • Du Bois RM, Nathan SD, Richeldi L, et al. Idiopathic pulmonary fibrosis: lung function is a clinically meaningful endpoint for phase 3 trials. Am J Respir Crit Care Med 2012; 186:712-715.
    • (2012) Am J Respir Crit Care Med , vol.186 , pp. 712-715
    • Du Bois, R.M.1    Nathan, S.D.2    Richeldi, L.3
  • 4
    • 84875208959 scopus 로고    scopus 로고
    • Forced vital capacity as a primary endpoint in idiopathic pulmonary fibrosis treatment trials: Making a silk purse from a sow's ear
    • Wells AU. Forced vital capacity as a primary endpoint in idiopathic pulmonary fibrosis treatment trials: making a silk purse from a sow's ear. Thorax 2013; 68:309-310.
    • (2013) Thorax , vol.68 , pp. 309-310
    • Wells, A.U.1
  • 5
    • 84898849450 scopus 로고    scopus 로고
    • Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: Provisional core sets of domains and instruments for use in clinical trials
    • Saketkoo LA, Mittoo S, Huscher D, et al. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials. Thorax 2014; 69:428-436.
    • (2014) Thorax , vol.69 , pp. 428-436
    • Saketkoo, L.A.1    Mittoo, S.2    Huscher, D.3
  • 6
    • 79960426037 scopus 로고    scopus 로고
    • Long-term course and prognosis of idiopathic pulmonary fibrosis in the modern era
    • Nathan SD, Shlobin OA, Weir N, et al. Long-term course and prognosis of idiopathic pulmonary fibrosis in the modern era. Chest 2011; 140:221-229.
    • (2011) Chest , vol.140 , pp. 221-229
    • Nathan, S.D.1    Shlobin, O.A.2    Weir, N.3
  • 7
    • 77951170794 scopus 로고    scopus 로고
    • Marginal decline in forced vital capacity is associated with a poor outcome in idiopathic pulmonary fibrosis
    • Zappala CJ, Latsi PI, Nicholson AG, et al. Marginal decline in forced vital capacity is associated with a poor outcome in idiopathic pulmonary fibrosis. Eur Respir J 2010; 35:830-836.
    • (2010) Eur Respir J , vol.35 , pp. 830-836
    • Zappala, C.J.1    Latsi, P.I.2    Nicholson, A.G.3
  • 8
    • 84455168726 scopus 로고    scopus 로고
    • Forced vital capacity in patients with idiopathic pulmonary fibrosis: Test properties and minimal clinically important difference
    • du Bois RM, Weycker D, Albera C, et al. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med 2011; 184: 1382-1389.
    • (2011) Am J Respir Crit Care Med , vol.184 , pp. 1382-1389
    • Du Bois, R.M.1    Weycker, D.2    Albera, C.3
  • 9
    • 84862826491 scopus 로고    scopus 로고
    • Relative versus absolute change in forced vital capacity in idiopathic pulmonary fibrosis
    • Richeldi L, Ryerson CJ, Lee JS, et al. Relative versus absolute change in forced vital capacity in idiopathic pulmonary fibrosis. Thorax 2012; 67:407-411.
    • (2012) Thorax , vol.67 , pp. 407-411
    • Richeldi, L.1    Ryerson, C.J.2    Lee, J.S.3
  • 10
    • 84901810710 scopus 로고    scopus 로고
    • Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis
    • Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014; 370:2071-2082.
    • (2014) N Engl J Med , vol.370 , pp. 2071-2082
    • Richeldi, L.1    Du Bois, R.M.2    Raghu, G.3
  • 11
    • 20544443765 scopus 로고    scopus 로고
    • The clinical course of patients with idiopathic pulmonary fibrosis
    • Martinez FJ, Safrin S, Weycker D, et al. The clinical course of patients with idiopathic pulmonary fibrosis. Ann Intern Med 2005; 142:963-967.
    • (2005) Ann Intern Med , vol.142 , pp. 963-967
    • Martinez, F.J.1    Safrin, S.2    Weycker, D.3
  • 12
    • 84901759236 scopus 로고    scopus 로고
    • A phase 3 trial of pirfe-nidone in patients with idiopathic pulmonary fibrosis
    • King TE, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfe-nidone in patients with idiopathic pulmonary fibrosis. N Engl J Med 2014; 370:2083-2092.
    • (2014) N Engl J Med , vol.370 , pp. 2083-2092
    • King, T.E.1    Bradford, W.Z.2    Castro-Bernardini, S.3
  • 13
    • 79956341531 scopus 로고    scopus 로고
    • Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): Two randomized trials
    • Noble PW, Albera C, Bradford WZ, et al. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomized trials. Lancet 2011; 377:1760-1769.
    • (2011) Lancet , vol.377 , pp. 1760-1769
    • Noble, P.W.1    Albera, C.2    Bradford, W.Z.3
  • 14
    • 84859918517 scopus 로고    scopus 로고
    • Pulmonary function vascular index predicts prognosis in idiopathic interstitial pneumonia
    • Corte TJ, Wort SJ, MacDonald PS, et al. Pulmonary function vascular index predicts prognosis in idiopathic interstitial pneumonia. Respirology 2012; 17:674-680.
    • (2012) Respirology , vol.17 , pp. 674-680
    • Corte, T.J.1    Wort, S.J.2    Macdonald, P.S.3
  • 15
    • 10744229010 scopus 로고    scopus 로고
    • Prognostic value of desaturation during a 6-min walk test in idiopathic interstitial pneumonia
    • Lama VN, Flaherty KR, Toews GB, et al. Prognostic value of desaturation during a 6-min walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med 2003; 168:1084-1090.
    • (2003) Am J Respir Crit Care Med , vol.168 , pp. 1084-1090
    • Lama, V.N.1    Flaherty, K.R.2    Toews, G.B.3
  • 16
    • 33748688190 scopus 로고    scopus 로고
    • Six-minute-walk distance predicts waiting list survival in idiopathic pulmonary fibrosis
    • Lederer DJ, Arcasoy SM, Wilt JS, et al. Six-minute-walk distance predicts waiting list survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2006; 174:659-664.
    • (2006) Am J Respir Crit Care Med , vol.174 , pp. 659-664
    • Lederer, D.J.1    Arcasoy, S.M.2    Wilt, J.S.3
  • 17
    • 57949084974 scopus 로고    scopus 로고
    • Walking distance on 6-MWT is a prognostic factor in idiopathic pulmonary fibrosis
    • Caminati A, Bianchi A, Cassandro R, et al. Walking distance on 6-MWT is a prognostic factor in idiopathic pulmonary fibrosis. Res Med 2009; 103:117-123.
    • (2009) Res Med , vol.103 , pp. 117-123
    • Caminati, A.1    Bianchi, A.2    Cassandro, R.3
  • 18
    • 33747820181 scopus 로고    scopus 로고
    • The distance saturation product: A novel measure for mortality prediction in idiopathic pulmonary fibrosis
    • Lettieri CJ, Browning RF, Shorr AF, et al. The distance saturation product: a novel measure for mortality prediction in idiopathic pulmonary fibrosis. Respir Med 2006; 100:1734-1741.
    • (2006) Respir Med , vol.100 , pp. 1734-1741
    • Lettieri, C.J.1    Browning, R.F.2    Shorr, A.F.3
  • 19
    • 79955520497 scopus 로고    scopus 로고
    • Six-minute-walk test in idiopathic pulmonary fibrosis: Test validation and minimal clinically important difference
    • Du Bois RM, Weycker D, Albera C, et al. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med 2011; 183:1231-1237.
    • (2011) Am J Respir Crit Care Med , vol.183 , pp. 1231-1237
    • Du Bois, R.M.1    Weycker, D.2    Albera, C.3
  • 20
    • 76549135612 scopus 로고    scopus 로고
    • The 6 min walk in idiopathic pulmonary fibrosis: Longitudinal changes and minimum important difference
    • Swigris JJ, Wamboldt FS, Behr J, et al. The 6 min walk in idiopathic pulmonary fibrosis: longitudinal changes and minimum important difference. Thorax 2010; 65:173-217.
    • (2010) Thorax , vol.65 , pp. 173-217
    • Swigris, J.J.1    Wamboldt, F.S.2    Behr, J.3
  • 21
    • 70149083664 scopus 로고    scopus 로고
    • Heart rate recovery after 6-minute walk test predicts survival in patients with idiopathic pulmonary fibrosis
    • Swigris JJ, Swick J, Wamboldt FS, et al. Heart rate recovery after 6-minute walk test predicts survival in patients with idiopathic pulmonary fibrosis. Chest 2009; 136:841-848.
    • (2009) Chest , vol.136 , pp. 841-848
    • Swigris, J.J.1    Swick, J.2    Wamboldt, F.S.3
  • 22
    • 79953279215 scopus 로고    scopus 로고
    • Heart rate recovery after 6MWT predicts pulmonary hypertension in patients with IPF
    • Swigris JJ, Olson A, Shlobin OA, et al. Heart rate recovery after 6MWT predicts pulmonary hypertension in patients with IPF. Respirology 2011; 16:439-445.
    • (2011) Respirology , vol.16 , pp. 439-445
    • Swigris, J.J.1    Olson, A.2    Shlobin, O.A.3
  • 23
    • 80052940121 scopus 로고    scopus 로고
    • Has my patient responded? Interpreting clinical measurements such as the 6-min-walk test
    • Dolmage TE, Hill K, Evans RA, Goldstein RS. Has my patient responded? Interpreting clinical measurements such as the 6-min-walk test. Am J Respir Crit Care Med 2011; 184:642-646.
    • (2011) Am J Respir Crit Care Med , vol.184 , pp. 642-646
    • Dolmage, T.E.1    Hill, K.2    Evans, R.A.3    Goldstein, R.S.4
  • 24
    • 84880086518 scopus 로고    scopus 로고
    • Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials
    • Collard HR, Yow E, Richeldi L, et al. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res 2013; 14:73.
    • (2013) Respir Res , vol.14 , pp. 73
    • Collard, H.R.1    Yow, E.2    Richeldi, L.3
  • 25
    • 84863450246 scopus 로고    scopus 로고
    • A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis
    • Noth I, Anstrom KJ, Calvert SB, et al. A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2012; 186:88-95.
    • (2012) Am J Respir Crit Care Med , vol.186 , pp. 88-95
    • Noth, I.1    Anstrom, K.J.2    Calvert, S.B.3
  • 26
    • 84861394764 scopus 로고    scopus 로고
    • Prednisone, azathioprine and N-acetylcysteine for pulmonary fibrosis
    • The Idiopathic Pulmonary Fibrosis Clinical Research Network
    • The Idiopathic Pulmonary Fibrosis Clinical Research Network. Prednisone, azathioprine and N-acetylcysteine for pulmonary fibrosis. N Engl J Med 2012; 366:1968-1977.
    • (2012) N Engl J Med , vol.366 , pp. 1968-1977
  • 27
    • 79951844263 scopus 로고    scopus 로고
    • Clinical course and prediction of survival in idiopathic pulmonaryfibrosis
    • Ley B, Collard HR, King TE. Clinical course and prediction of survival in idiopathic pulmonaryfibrosis. Am J Respir Crit Care Med 2011; 183:431-440.
    • (2011) Am J Respir Crit Care Med , vol.183 , pp. 431-440
    • Ley, B.1    Collard, H.R.2    King, T.E.3
  • 28
    • 84897459884 scopus 로고    scopus 로고
    • All-cause mortality rate in patients with idiopathic pulmonary fibrosis: Implications for the design and execution of clinical trials
    • King TE Jr, Albera C, Bradford WZ, et al. All-cause mortality rate in patients with idiopathic pulmonary fibrosis: implications for the design and execution of clinical trials. Am J Respir Crit Care Med 2014; 189:825-831.
    • (2014) Am J Respir Crit Care Med , vol.189 , pp. 825-831
    • King Jr., T.E.1    Albera, C.2    Bradford, W.Z.3
  • 29
    • 0025248164 scopus 로고
    • Clinical deterioration in patients with idiopathic pulmonary fibrosis: Causes and assessment
    • Panos R. Clinical deterioration in patients with idiopathic pulmonary fibrosis: causes and assessment. Am J Med 1990; 88:396-404.
    • (1990) Am J Med , vol.88 , pp. 396-404
    • Panos, R.1
  • 30
    • 74549213651 scopus 로고    scopus 로고
    • Trial and error: How to avoid commonly encountered limitations of published clinical trials
    • Kaul S, Diamond GA. Trial and error: how to avoid commonly encountered limitations of published clinical trials. J Am Coll Cardiol 2010; 55:415-427.
    • (2010) J Am Coll Cardiol , vol.55 , pp. 415-427
    • Kaul, S.1    Diamond, G.A.2
  • 31
    • 83555164738 scopus 로고    scopus 로고
    • Quantitative texture-based assessment of one-year changes in fibrotic reticular patterns on HRCT in scleroderma lung disease treated with oral cyclophosphamide
    • Kim HJ, Brown MS, Elashoff R, et al. Quantitative texture-based assessment of one-year changes in fibrotic reticular patterns on HRCT in scleroderma lung disease treated with oral cyclophosphamide. Eur Radiol 2011; 21:2455-2465.
    • (2011) Eur Radiol , vol.21 , pp. 2455-2465
    • Kim, H.J.1    Brown, M.S.2    Elashoff, R.3
  • 32
    • 0030886936 scopus 로고    scopus 로고
    • Thin-section CT obtained at 10-mm increments versus limited three-level thin-section CT for idiopathic pulmonary fibrosis: Correlation with pathologic scoring
    • Kazerooni EA, Martinez FJ, Flint A, et al. Thin-section CT obtained at 10-mm increments versus limited three-level thin-section CT for idiopathic pulmonary fibrosis: correlation with pathologic scoring. AJR 1997; 169:977-983.
    • (1997) AJR , vol.169 , pp. 977-983
    • Kazerooni, E.A.1    Martinez, F.J.2    Flint, A.3
  • 33
    • 84864815252 scopus 로고    scopus 로고
    • Patient-reported outcomes in idiopathic pulmonary fibrosis research
    • Swigris JJ, Fairclough D. Patient-reported outcomes in idiopathic pulmonary fibrosis research. Chest 2012; 142:291-297.
    • (2012) Chest , vol.142 , pp. 291-297
    • Swigris, J.J.1    Fairclough, D.2
  • 34
    • 77957202563 scopus 로고    scopus 로고
    • Development and validity testing of an IPF-specific version of the St George's Respiratory Questionnaire
    • Yorke J, Jones PW, Swigris JJ. Development and validity testing of an IPF-specific version of the St George's Respiratory Questionnaire. Thorax 2010; 65:921-926.
    • (2010) Thorax , vol.65 , pp. 921-926
    • Yorke, J.1    Jones, P.W.2    Swigris, J.J.3
  • 35
    • 77955074501 scopus 로고    scopus 로고
    • Development of the ATAQ-IPF: A tool to assess quality of life in IPF
    • Swigris JJ, Wilson SR, Green KE, et al. Development of the ATAQ-IPF: a tool to assess quality of life in IPF. Health Qual Life Outcomes 2010; 8:77.
    • (2010) Health Qual Life Outcomes , vol.8 , pp. 77
    • Swigris, J.J.1    Wilson, S.R.2    Green, K.E.3
  • 36
    • 64749097794 scopus 로고    scopus 로고
    • Serum albumen concentration and waiting list mortality in idiopathic interstitial pneumonia
    • Zisman DA, Kawut SM, Lederer DJ, et al. Serum albumen concentration and waiting list mortality in idiopathic interstitial pneumonia. Chest 2009; 135:929-935.
    • (2009) Chest , vol.135 , pp. 929-935
    • Zisman, D.A.1    Kawut, S.M.2    Lederer, D.J.3
  • 37
    • 33644828168 scopus 로고    scopus 로고
    • Prognostic value of circulating kl-6 in idiopathic pulmonary fibrosis
    • Yokoyama A, Kondo K, Nakajima M, et al. Prognostic value of circulating kl-6 in idiopathic pulmonary fibrosis. Respirology 2006; 11:164-168.
    • (2006) Respirology , vol.11 , pp. 164-168
    • Yokoyama, A.1    Kondo, K.2    Nakajima, M.3
  • 38
    • 63849228099 scopus 로고    scopus 로고
    • Serum surfactant protein-A is a strong predictor of early mortality in idiopathic pulmonary fibrosis
    • Kinder BW, Brown KK, McCormack FX, et al. Serum surfactant protein-A is a strong predictor of early mortality in idiopathic pulmonary fibrosis. Chest 2009; 135:1557-1563.
    • (2009) Chest , vol.135 , pp. 1557-1563
    • Kinder, B.W.1    Brown, K.K.2    McCormack, F.X.3
  • 39
    • 84855264195 scopus 로고    scopus 로고
    • Peripheral blood proteins predict mortality in idiopathic pulmonary fibrosis
    • Richards TJ, Kaminski N, Baribaud F, et al. Peripheral blood proteins predict mortality in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2012; 185:67-76.
    • (2012) Am J Respir Crit Care Med , vol.185 , pp. 67-76
    • Richards, T.J.1    Kaminski, N.2    Baribaud, F.3
  • 40
    • 84878585570 scopus 로고    scopus 로고
    • The red cell distribution width as a prognostic indicator in IPF
    • Nathan SD, Reffett T, Brown AW, et al. The red cell distribution width as a prognostic indicator in IPF. Chest 2013; 143:1692-1698.
    • (2013) Chest , vol.143 , pp. 1692-1698
    • Nathan, S.D.1    Reffett, T.2    Brown, A.W.3
  • 41
    • 58249092608 scopus 로고    scopus 로고
    • Echocardiography and brain natriuretic peptide as prognostic indicators in idiopathic pulmonary fibrosis
    • Song JW, Song JK, Kim DS. Echocardiography and brain natriuretic peptide as prognostic indicators in idiopathic pulmonary fibrosis. Res Med 2009; 103:180-186.
    • (2009) Res Med , vol.103 , pp. 180-186
    • Song, J.W.1    Song, J.K.2    Kim, D.S.3
  • 42
    • 33645297106 scopus 로고    scopus 로고
    • Brain natruiretic peptide is a prognostic parameter in chronic lung disease
    • Leuchte HH, Baumgartner RA, Nounou ME, et al. Brain natruiretic peptide is a prognostic parameter in chronic lung disease. Am J Respir Crit Care Med 2006; 173:744-750.
    • (2006) Am J Respir Crit Care Med , vol.173 , pp. 744-750
    • Leuchte, H.H.1    Baumgartner, R.A.2    Nounou, M.E.3
  • 43
    • 77957852320 scopus 로고    scopus 로고
    • Elevated brain natriuretic peptide predicts mortality in interstitial lung disease
    • Corte TJ, Wort SJ, Gatzoulis MA, et al. Elevated brain natriuretic peptide predicts mortality in interstitial lung disease. Eur Respir J 2010; 36:819-825.
    • (2010) Eur Respir J , vol.36 , pp. 819-825
    • Corte, T.J.1    Wort, S.J.2    Gatzoulis, M.A.3
  • 44
    • 84881669432 scopus 로고    scopus 로고
    • ATS/ERS Committee on Idiopathic Interstitial Pneumonias. An official American Thoracic Society/European Respiratory Society statement: Update of the international multidisciplinary classification of the idiopathic interstitial pneumonias
    • Travis WD, Costabel U, Hansell DM, et al. ATS/ERS Committee on Idiopathic Interstitial Pneumonias. An official American Thoracic Society/European Respiratory Society statement: update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med 2013; 188:733-748.
    • (2013) Am J Respir Crit Care Med , vol.188 , pp. 733-748
    • Travis, W.D.1    Costabel, U.2    Hansell, D.M.3
  • 46
    • 84855264195 scopus 로고    scopus 로고
    • Peripheral blood proteins predict mortality in idiopathic pulmonary fibrosis
    • Richards TJ, Kaminski N, Baribaud F, et al. Peripheral blood proteins predict mortality in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2012; 185:67-76.
    • (2012) Am J Respir Crit Care Med , vol.185 , pp. 67-76
    • Richards, T.J.1    Kaminski, N.2    Baribaud, F.3
  • 47
    • 84885467568 scopus 로고    scopus 로고
    • Peripheral blood mononuclear cell gene expression profiles predict poor outcome in idiopathic pulmonary fibrosis
    • Herazo-Maya JD, Noth I, Duncan SR, et al. Peripheral blood mononuclear cell gene expression profiles predict poor outcome in idiopathic pulmonary fibrosis. Sci Transl Med 2013; 5:205ra136.
    • (2013) Sci Transl Med , vol.5
    • Herazo-Maya, J.D.1    Noth, I.2    Duncan, S.R.3
  • 48
    • 34247618238 scopus 로고    scopus 로고
    • Idiopathic pulmonary fibrosis and pul monary hypertension: Connecting the dots
    • Nathan SD, Noble PW, Tuder RM. Idiopathic pulmonary fibrosis and pul monary hypertension: connecting the dots. Am J Respir Crit Care Med 2007; 175:875-880.
    • (2007) Am J Respir Crit Care Med , vol.175 , pp. 875-880
    • Nathan, S.D.1    Noble, P.W.2    Tuder, R.M.3


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