Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral 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 ILD associated with SSc.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

Criteria

Main inclusion criteria:

• Systemic Sclerosis diffuse or limited

• Significant Interstitial Lung Disease on HRCTscan

• DLco < 80% predicted

• Dyspnea on exertion

• Walk not limited by musculoskeletal reasons

Main exclusion criteria:

• Interstitial Lung Disease due to other conditions than SSc

• End stage restrictive or obstructive lung disease

• Severe cardiac or renal diseases

• Significant pulmonary arterial hypertension

• Smoker (> 5cig./day)

• Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)