Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

Harold R. Collard, Eric Yow, Luca Richeldi, Kevin J. Anstrom, Craig Glazer, M. Schwarz, D. A. Zisman, G. Hunninghake, J. Chapman, M. Olman, S. Lubell, L. D. Morrison, M. P. Steele, T. Haram, J. Roman, R. Perez, T. Perez, J. H. Ryu, J. P. Utz, A. H. LimperC. E. Daniels, K. Meiras, S. Walsh, K. K. Brown, C. Bair, D. Kervitsky, J. A. Lasky, S. Ditta, J. De Andrade, V. J. Thannickal, M. Stewart, J. Lynch, E. Calahan, P. Lopez, T. E. King, H. R. Collard, J. A. Golden, P. J. Wolters, R. Jeffrey, I. Noth, D. K. Hogarth, N. Sandbo, M. E. Strek, S. R. White, C. Brown, I. Garic, S. Maleckar, F. J. Martinez, K. R. Flaherty, M. Han, B. Moore, G. B. Toews, D. Dahlgren, G. Raghu, J. Hayes, M. Snyder, J. E. Loyd, L. Lancaster, W. Lawson, R. Greer, W. Mason, R. J. Kaner, V. Monroy, M. Wang, D. A. Lynch, T. Colby, R. C. Becker, E. L. Eisenstein, N. R. MacIntyre, J. Rochon, J. S. Sundy, L. Davidson-Ray, P. Dignacco, R. Edwards, R. Anderson, R. Beci, S. Calvert, K. Cain, T. Gentry-Bumpass, D. Hill, M. Ingham, E. Kagan, J. Kaur, C. Matti, J. McClelland, A. Meredith, T. Nguyen, J. Pesarchick, R. S. Roberts, W. Tate, T. Thomas, J. Walker, D. Whelan, J. Winsor, Q. Yang, H. Y. Reynolds, X. Tian, J. Kiley

Research output: Contribution to journalArticle

90 Citations (Scopus)

Abstract

Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.

Original languageEnglish (US)
Article number73
JournalRespiratory Research
Volume14
Issue number1
DOIs
StatePublished - Jul 13 2013

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Idiopathic Pulmonary Fibrosis
Outcome Assessment (Health Care)
Clinical Trials
Disease Progression
Research Personnel
Mortality

Keywords

  • Acute exacerbation
  • Clinical trials
  • Endpoints
  • Pulmonary fibrosis

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. / Collard, Harold R.; Yow, Eric; Richeldi, Luca; Anstrom, Kevin J.; Glazer, Craig; Schwarz, M.; Zisman, D. A.; Hunninghake, G.; Chapman, J.; Olman, M.; Lubell, S.; Morrison, L. D.; Steele, M. P.; Haram, T.; Roman, J.; Perez, R.; Perez, T.; Ryu, J. H.; Utz, J. P.; Limper, A. H.; Daniels, C. E.; Meiras, K.; Walsh, S.; Brown, K. K.; Bair, C.; Kervitsky, D.; Lasky, J. A.; Ditta, S.; De Andrade, J.; Thannickal, V. J.; Stewart, M.; Lynch, J.; Calahan, E.; Lopez, P.; King, T. E.; Collard, H. R.; Golden, J. A.; Wolters, P. J.; Jeffrey, R.; Noth, I.; Hogarth, D. K.; Sandbo, N.; Strek, M. E.; White, S. R.; Brown, C.; Garic, I.; Maleckar, S.; Martinez, F. J.; Flaherty, K. R.; Han, M.; Moore, B.; Toews, G. B.; Dahlgren, D.; Raghu, G.; Hayes, J.; Snyder, M.; Loyd, J. E.; Lancaster, L.; Lawson, W.; Greer, R.; Mason, W.; Kaner, R. J.; Monroy, V.; Wang, M.; Lynch, D. A.; Colby, T.; Becker, R. C.; Eisenstein, E. L.; MacIntyre, N. R.; Rochon, J.; Sundy, J. S.; Davidson-Ray, L.; Dignacco, P.; Edwards, R.; Anderson, R.; Beci, R.; Calvert, S.; Cain, K.; Gentry-Bumpass, T.; Hill, D.; Ingham, M.; Kagan, E.; Kaur, J.; Matti, C.; McClelland, J.; Meredith, A.; Nguyen, T.; Pesarchick, J.; Roberts, R. S.; Tate, W.; Thomas, T.; Walker, J.; Whelan, D.; Winsor, J.; Yang, Q.; Reynolds, H. Y.; Tian, X.; Kiley, J.

In: Respiratory Research, Vol. 14, No. 1, 73, 13.07.2013.

Research output: Contribution to journalArticle

Collard, HR, Yow, E, Richeldi, L, Anstrom, KJ, Glazer, C, Schwarz, M, Zisman, DA, Hunninghake, G, Chapman, J, Olman, M, Lubell, S, Morrison, LD, Steele, MP, Haram, T, Roman, J, Perez, R, Perez, T, Ryu, JH, Utz, JP, Limper, AH, Daniels, CE, Meiras, K, Walsh, S, Brown, KK, Bair, C, Kervitsky, D, Lasky, JA, Ditta, S, De Andrade, J, Thannickal, VJ, Stewart, M, Lynch, J, Calahan, E, Lopez, P, King, TE, Collard, HR, Golden, JA, Wolters, PJ, Jeffrey, R, Noth, I, Hogarth, DK, Sandbo, N, Strek, ME, White, SR, Brown, C, Garic, I, Maleckar, S, Martinez, FJ, Flaherty, KR, Han, M, Moore, B, Toews, GB, Dahlgren, D, Raghu, G, Hayes, J, Snyder, M, Loyd, JE, Lancaster, L, Lawson, W, Greer, R, Mason, W, Kaner, RJ, Monroy, V, Wang, M, Lynch, DA, Colby, T, Becker, RC, Eisenstein, EL, MacIntyre, NR, Rochon, J, Sundy, JS, Davidson-Ray, L, Dignacco, P, Edwards, R, Anderson, R, Beci, R, Calvert, S, Cain, K, Gentry-Bumpass, T, Hill, D, Ingham, M, Kagan, E, Kaur, J, Matti, C, McClelland, J, Meredith, A, Nguyen, T, Pesarchick, J, Roberts, RS, Tate, W, Thomas, T, Walker, J, Whelan, D, Winsor, J, Yang, Q, Reynolds, HY, Tian, X & Kiley, J 2013, 'Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials', Respiratory Research, vol. 14, no. 1, 73. https://doi.org/10.1186/1465-9921-14-73
Collard, Harold R. ; Yow, Eric ; Richeldi, Luca ; Anstrom, Kevin J. ; Glazer, Craig ; Schwarz, M. ; Zisman, D. A. ; Hunninghake, G. ; Chapman, J. ; Olman, M. ; Lubell, S. ; Morrison, L. D. ; Steele, M. P. ; Haram, T. ; Roman, J. ; Perez, R. ; Perez, T. ; Ryu, J. H. ; Utz, J. P. ; Limper, A. H. ; Daniels, C. E. ; Meiras, K. ; Walsh, S. ; Brown, K. K. ; Bair, C. ; Kervitsky, D. ; Lasky, J. A. ; Ditta, S. ; De Andrade, J. ; Thannickal, V. J. ; Stewart, M. ; Lynch, J. ; Calahan, E. ; Lopez, P. ; King, T. E. ; Collard, H. R. ; Golden, J. A. ; Wolters, P. J. ; Jeffrey, R. ; Noth, I. ; Hogarth, D. K. ; Sandbo, N. ; Strek, M. E. ; White, S. R. ; Brown, C. ; Garic, I. ; Maleckar, S. ; Martinez, F. J. ; Flaherty, K. R. ; Han, M. ; Moore, B. ; Toews, G. B. ; Dahlgren, D. ; Raghu, G. ; Hayes, J. ; Snyder, M. ; Loyd, J. E. ; Lancaster, L. ; Lawson, W. ; Greer, R. ; Mason, W. ; Kaner, R. J. ; Monroy, V. ; Wang, M. ; Lynch, D. A. ; Colby, T. ; Becker, R. C. ; Eisenstein, E. L. ; MacIntyre, N. R. ; Rochon, J. ; Sundy, J. S. ; Davidson-Ray, L. ; Dignacco, P. ; Edwards, R. ; Anderson, R. ; Beci, R. ; Calvert, S. ; Cain, K. ; Gentry-Bumpass, T. ; Hill, D. ; Ingham, M. ; Kagan, E. ; Kaur, J. ; Matti, C. ; McClelland, J. ; Meredith, A. ; Nguyen, T. ; Pesarchick, J. ; Roberts, R. S. ; Tate, W. ; Thomas, T. ; Walker, J. ; Whelan, D. ; Winsor, J. ; Yang, Q. ; Reynolds, H. Y. ; Tian, X. ; Kiley, J. / Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. In: Respiratory Research. 2013 ; Vol. 14, No. 1.
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abstract = "Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.",
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TY - JOUR

T1 - Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

AU - Collard, Harold R.

AU - Yow, Eric

AU - Richeldi, Luca

AU - Anstrom, Kevin J.

AU - Glazer, Craig

AU - Schwarz, M.

AU - Zisman, D. A.

AU - Hunninghake, G.

AU - Chapman, J.

AU - Olman, M.

AU - Lubell, S.

AU - Morrison, L. D.

AU - Steele, M. P.

AU - Haram, T.

AU - Roman, J.

AU - Perez, R.

AU - Perez, T.

AU - Ryu, J. H.

AU - Utz, J. P.

AU - Limper, A. H.

AU - Daniels, C. E.

AU - Meiras, K.

AU - Walsh, S.

AU - Brown, K. K.

AU - Bair, C.

AU - Kervitsky, D.

AU - Lasky, J. A.

AU - Ditta, S.

AU - De Andrade, J.

AU - Thannickal, V. J.

AU - Stewart, M.

AU - Lynch, J.

AU - Calahan, E.

AU - Lopez, P.

AU - King, T. E.

AU - Collard, H. R.

AU - Golden, J. A.

AU - Wolters, P. J.

AU - Jeffrey, R.

AU - Noth, I.

AU - Hogarth, D. K.

AU - Sandbo, N.

AU - Strek, M. E.

AU - White, S. R.

AU - Brown, C.

AU - Garic, I.

AU - Maleckar, S.

AU - Martinez, F. J.

AU - Flaherty, K. R.

AU - Han, M.

AU - Moore, B.

AU - Toews, G. B.

AU - Dahlgren, D.

AU - Raghu, G.

AU - Hayes, J.

AU - Snyder, M.

AU - Loyd, J. E.

AU - Lancaster, L.

AU - Lawson, W.

AU - Greer, R.

AU - Mason, W.

AU - Kaner, R. J.

AU - Monroy, V.

AU - Wang, M.

AU - Lynch, D. A.

AU - Colby, T.

AU - Becker, R. C.

AU - Eisenstein, E. L.

AU - MacIntyre, N. R.

AU - Rochon, J.

AU - Sundy, J. S.

AU - Davidson-Ray, L.

AU - Dignacco, P.

AU - Edwards, R.

AU - Anderson, R.

AU - Beci, R.

AU - Calvert, S.

AU - Cain, K.

AU - Gentry-Bumpass, T.

AU - Hill, D.

AU - Ingham, M.

AU - Kagan, E.

AU - Kaur, J.

AU - Matti, C.

AU - McClelland, J.

AU - Meredith, A.

AU - Nguyen, T.

AU - Pesarchick, J.

AU - Roberts, R. S.

AU - Tate, W.

AU - Thomas, T.

AU - Walker, J.

AU - Whelan, D.

AU - Winsor, J.

AU - Yang, Q.

AU - Reynolds, H. Y.

AU - Tian, X.

AU - Kiley, J.

PY - 2013/7/13

Y1 - 2013/7/13

N2 - Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.

AB - Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures.

KW - Acute exacerbation

KW - Clinical trials

KW - Endpoints

KW - Pulmonary fibrosis

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