We are pleased to have been a study site for the INSPIRE trial. This was a multi-center phase III study to examine the effect of gamma interferon 1b in early stage idiopathic pulmonary fibrosis (IPF). It was a placebo controlled study with a 2:1 randomization (2 subjects will receive gamma interferon for every 1 that receives placebo); a total of 826 patients were entered into the study. The study was initially planned to proceed through the fall of 2008. An interim analysis of the data in March, 2007 resulted in early discontinuation of the study when it was determined that gamma interferon had no effect on survival in idiopathic pulmonary fibrosis.
Although the results of this study are disappointing, we are now enrolling patients in the CAPACITY trial of pirfenidone in early stage IPF.