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. Limper; C. 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

doi:10.1186/1465-9921-14-73

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 journal › Article › peer-review

119 Scopus citations

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 language	English (US)
Article number	73
Journal	Respiratory Research
Volume	14
Issue number	1
DOIs	https://doi.org/10.1186/1465-9921-14-73
State	Published - Jul 13 2013

Keywords

Acute exacerbation
Clinical trials
Endpoints
Pulmonary fibrosis

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

Access to Document

10.1186/1465-9921-14-73

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Collard, H. R., Yow, E., Richeldi, L., Anstrom, K. J., Glazer, C., 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., ... Kiley, J. (2013). Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respiratory Research, 14(1), Article 73. https://doi.org/10.1186/1465-9921-14-73

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

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title = "Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials",

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.",

keywords = "Acute exacerbation, Clinical trials, Endpoints, Pulmonary fibrosis",

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

year = "2013",

month = jul,

day = "13",

doi = "10.1186/1465-9921-14-73",

language = "English (US)",

volume = "14",

journal = "Respiratory Research",

issn = "1465-9921",

publisher = "BioMed Central",

number = "1",

}

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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UR - http://www.scopus.com/inward/citedby.url?scp=84880086518&partnerID=8YFLogxK

U2 - 10.1186/1465-9921-14-73

DO - 10.1186/1465-9921-14-73

M3 - Article

C2 - 23848435

AN - SCOPUS:84880086518

SN - 1465-9921

VL - 14

JO - Respiratory Research

JF - Respiratory Research

IS - 1

M1 - 73

ER -

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

Abstract

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