Abstract
Introduction: ASCEND is a Phase 3 trial evaluating pirfenidone in IPF. Design modifications (vs. CAP) included a 1 year treatment period; centralised procedures for diagnosis, spirometry, and mortality adjudication; and modification of eligibility criteria to enrol patients with greater risk for disease progression.
Objective: Assess the effect of design modifications on IPF trial outcomes.
Methods: Modified criteria for ASCEND included: IPF diagnosis ≥6 months prior to randomization (vs. no time limit in CAP); % predicted forced vital capacity (%FVC) ≥50% and ≤90% and % predicted carbon monoxide diffusing capacity (%DLco) ≥30% and ≤90% (vs. %FVC or %DLco ≤90% in CAP); and forced expiratory volume in 1 second (FEV1)/FVC ratio ≥0.80 (vs. ≥0.70 in CAP). Central review of HRCT scans and lung biopsies was implemented to minimiseheterogeneity.
Results: Baseline characteristics in the ASCEND and CAP studies are summarized in Table 1. Lower median values for %FVC and %DLCO and a longer median time since diagnosis were observed in ASCEND.
Conclusions: Baseline characteristics in ASCEND were generally similar to those in CAP. Notable differences included lower %FVC and %DLCO and a longer time since diagnosis in ASCEND, each of which has been shown to be independently associated with a higher risk of FVC decline.
- © 2014 ERS