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

Phase 2

Completed

• Conditions: Pulmonary Fibrosis; Scleroderma, Systemic

• Registration Number: NCT00070590
• Lead Sponsor: Actelion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-10-06
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Disposition First Submitted: 2010-02-11
• Disposition First Submitted QC: 2010-02-11
• Disposition First Posted: 2010-02-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to End-of-Study in 6-minute walk distance.

Secondary Outcome Measures

Name	Time	Method
Time to death (all causes) or to worsening of PFTs up to End-of-Study.
Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC