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

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00070590
First received: October 6, 2003
Last updated: February 11, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Scleroderma, Systemic
 Drug: Bosentan
 Phase 2
Phase 3

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

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change from baseline to End-of-Study in 6-minute walk distance.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 132
Study Start Date: July 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070590

  Hide Study Locations
Locations
United States, California
UCLA Med School
Los Angeles, California, United States, 90095
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Illinois
University of Illinois College of Medicine
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston Univ School of Medicine
Boston, Massachusetts, United States, 02118
United States, New Jersey
UMDNJ
New Brunswick, New Jersey, United States, 08903
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19004
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15267
United States, South Carolina
Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Houston Medical School
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
France
Centre Hospitalier Universitaire
Grenoble, France
CHRU Claude Huriez
Lille, France
Hôpital Saint Antoine
Paris, France
Hôpital Cochin
Paris, France
Germany
Charité Universitätsklinikum
Berlin, Germany
Israel
Rabin Medical Center
Petach Tikva, Israel
Italy
Instituto di Clinica, Villa Monna Tessa
Firenze, Italy
Ospedale Maggiore
Milano, Italy
Policlinico Universitario
Padova, Italy
Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands
Sweden
University Hospital
Lund, Sweden
Switzerland
University Hospital
Zurich, Switzerland
United Kingdom
General Infirmary
Leeds, United Kingdom
Royal Free Hospital
London, United Kingdom
Sponsors and Collaborators
Actelion
  More Information

No publications provided by Actelion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00070590     History of Changes
Other Study ID Numbers: AC-052-330, BUILD 2
Study First Received: October 6, 2003
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Scleroderma
Fibrosing alveolitis
Build
bosentan

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Fibrosis
Pulmonary Fibrosis
Lung Diseases, Interstitial
Connective Tissue Diseases
Skin Diseases
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013