CompletedPhase 2/3

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

132 participantsStarted 2003-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Trial details

NCT IDNCT00070590

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-09

View on ClinicalTrials.gov More Pulmonary Fibrosis trials