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

Respiratory Research

Craig Glazer³  Kevin J Anstrom²  Luca Richeldi⁴  Eric Yow²  Harold R Collard¹ 

[1] University of California San Francisco, 505 Parnassus Avenue, San Francisco, CA, USA;Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC, USA;University of Texas Southwestern, 5323 Harry Hines Blvd, Dallas, TX, USA;University Hospital of Modena, Via del Pozzo 71, Modena, Italy

关键词: Pulmonary fibrosis;    Acute exacerbation;    Endpoints;    Clinical trials;   

Others  :  793128
DOI  :  10.1186/1465-9921-14-73

 received in 2013-04-10, accepted in 2013-07-08,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Collard et al.; licensee BioMed Central Ltd.

【 图 表 】

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