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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070590
• Other study ID #: AC-052-330
• Secondary ID: BUILD 2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 6, 2003
• Last updated: February 11, 2010
• Start date: July 2003
• Est. completion date: September 2005

Study information

• Verified date: February 2010
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Pulmonary Fibrosis
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Drug:
• Bosentan

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Grenoble
France	CHRU Claude Huriez	Lille
France	Hôpital Cochin	Paris
France	Hôpital Saint Antoine	Paris
Germany	Charité Universitätsklinikum	Berlin
Israel	Rabin Medical Center	Petach Tikva
Italy	Instituto di Clinica, Villa Monna Tessa	Firenze
Italy	Ospedale Maggiore	Milano
Italy	Policlinico Universitario	Padova
Netherlands	Sint Maartenskliniek	Nijmegen
Sweden	University Hospital	Lund
Switzerland	University Hospital	Zurich
United Kingdom	General Infirmary	Leeds
United Kingdom	Royal Free Hospital	London
United States	The Center for Rheumatology	Albany	New York
United States	Boston Univ School of Medicine	Boston	Massachusetts
United States	Medical Univ of South Carolina	Charleston	South Carolina
United States	University of Illinois College of Medicine	Chicago	Illinois
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	University of Texas Houston Medical School	Houston	Texas
United States	UCLA Med School	Los Angeles	California
United States	Jackson Memorial Hospital	Miami	Florida
United States	UMDNJ	New Brunswick	New Jersey
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  France,  Germany,  Israel,  Italy,  Netherlands,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to End-of-Study in 6-minute walk distance.
Secondary	Time to death (all causes) or to worsening of PFTs up to End-of-Study.
Secondary	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