Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
- Conditions
- Pulmonary FibrosisScleroderma, 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Not provided
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
Trial Locations
- Locations (28)
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
UMDNJ
🇺🇸New Brunswick, New Jersey, United States
Denver Health Medical Center
🇺🇸Denver, Colorado, United States
UCLA Med School
🇺🇸Los Angeles, California, United States
CHRU Claude Huriez
🇫🇷Lille, France
The Center for Rheumatology
🇺🇸Albany, New York, United States
University of Illinois College of Medicine
🇺🇸Chicago, Illinois, United States
Boston Univ School of Medicine
🇺🇸Boston, Massachusetts, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Medical Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
Hôpital Saint Antoine
🇫🇷Paris, France
University of Texas Houston Medical School
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Centre Hospitalier Universitaire
🇫🇷Grenoble, France
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Hôpital Cochin
🇫🇷Paris, France
Charité Universitätsklinikum
🇩🇪Berlin, Germany
Instituto di Clinica, Villa Monna Tessa
🇮🇹Firenze, Italy
University Hospital
🇨ðŸ‡Zurich, Switzerland
Policlinico Universitario
🇮🇹Padova, Italy
Sint Maartenskliniek
🇳🇱Nijmegen, Netherlands
Ospedale Maggiore
🇮🇹Milano, Italy
Royal Free Hospital
🇬🇧London, United Kingdom
General Infirmary
🇬🇧Leeds, United Kingdom
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States