BUILD 3: Bosentan Use in Interstitial Lung Disease

Phase 3 Completed 616 enrolled Actelion

RandomizedParallel-groupQuadruple-blindTreatment

Summary

BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

Timeline

Start: 2007-02
Primary completion: 2010-02
Completion: 2010-07

Outcome

Missed primary endpoint

registry analysis (unspecified test); Placebo vs Bosentan; p = 0.2110; Hazard Ratio (HR) 0.850 (95% CI 0.658 to 1.097); Log Rank NCT00391443 ↗

paper The primary objective in the Bosentan Use in Interstitial Lung Disease-3 trial was not met. PMID 21474646 ↗

Publications

King TE Jr, Brown KK, Raghu G, du Bois RM, Lynch DA, Martinez F, Valeyre D, Leconte I, Morganti A, Roux S, Behr J. BUILD-3: a randomized, controlled trial of bosentan in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Jul 1;184(1):92-9. doi: 10.1164/rccm.201011-1874OC. Epub 2011 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosentan	Other / unclassified	62.5 mg	—
Subject	Bosentan	Other / unclassified	125 mg	—