A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

Actelion0 sites132 target enrollmentJuly 2003

ConditionsPulmonary Fibrosis Scleroderma, Systemic

DrugsBosentan

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary Fibrosis
Sponsor: Actelion
Enrollment: 132
Primary Endpoint: Change from baseline to End-of-Study in 6-minute walk distance.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

September 2005

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actelion

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

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