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

Tracking Information
First Received Date ^ICMJE	October 6, 2003
Last Updated Date	January 29, 2009
Start Date ^ICMJE	July 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 21, 2006)	Change from baseline to End-of-Study in 6-minute walk distance.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00070590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 21, 2006)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
Official Title ^ICMJE	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
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
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pulmonary Fibrosis Scleroderma, Systemic
Intervention ^ICMJE	Drug: Bosentan
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	132
Completion Date	September 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Israel, Italy, Netherlands, Sweden, Switzerland, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00070590
Responsible Party
Study ID Numbers ^ICMJE	AC-052-330, BUILD 2
Study Sponsor ^ICMJE	Actelion
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Actelion
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP