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

Publication ,  Journal Article
Collard, HR; Yow, E; Richeldi, L; Anstrom, KJ; Glazer, C; IPFnet investigators,
Published in: Respir Res
July 13, 2013

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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Published In

Respir Res

DOI

EISSN

1465-993X

Publication Date

July 13, 2013

Volume

14

Issue

1

Start / End Page

73

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sulfones
  • Sildenafil Citrate
  • Sensitivity and Specificity
  • Respiratory System
  • Reproducibility of Results
  • Purines
  • Piperazines
  • Phosphodiesterase 5 Inhibitors
  • Outcome Assessment, Health Care
 

Citation

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Collard, H. R., Yow, E., Richeldi, L., Anstrom, K. J., Glazer, C., & IPFnet investigators, . (2013). Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res, 14(1), 73. https://doi.org/10.1186/1465-9921-14-73
Collard, Harold R., Eric Yow, Luca Richeldi, Kevin J. Anstrom, Craig Glazer, and Craig IPFnet investigators. “Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials.Respir Res 14, no. 1 (July 13, 2013): 73. https://doi.org/10.1186/1465-9921-14-73.
Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C, IPFnet investigators. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013 Jul 13;14(1):73.
Collard, Harold R., et al. “Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials.Respir Res, vol. 14, no. 1, July 2013, p. 73. Pubmed, doi:10.1186/1465-9921-14-73.
Collard HR, Yow E, Richeldi L, Anstrom KJ, Glazer C, IPFnet investigators. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013 Jul 13;14(1):73.

Published In

Respir Res

DOI

EISSN

1465-993X

Publication Date

July 13, 2013

Volume

14

Issue

1

Start / End Page

73

Location

England

Related Subject Headings

  • Treatment Outcome
  • Sulfones
  • Sildenafil Citrate
  • Sensitivity and Specificity
  • Respiratory System
  • Reproducibility of Results
  • Purines
  • Piperazines
  • Phosphodiesterase 5 Inhibitors
  • Outcome Assessment, Health Care