NCT00071461

Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF. It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	bosentan	Initial dose: 62.5 mg b.i.d. for 4 weeks. * Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). * body weight \< 40 kg (90 lb): 62.5 mg b.i.d.
DRUG	Placebo	Initial dose: 62.5 mg b.i.d. for 4 weeks. * Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated). * body weight \< 40 kg (90 lb): 62.5 mg b.i.d.

Timeline

• Start date: 2003-08-01
• Primary completion: 2005-09-01
• Completion: 2010-05-01
• First posted: 2003-10-24
• Last updated: 2012-02-24

Locations

29 sites across 8 countries: United States, Canada, France, Germany, Israel, Italy, Switzerland, United Kingdom