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 clinicall

SUBMITTER: Collard HR 

PROVIDER: S-EPMC3729659 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature