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

February 11, 2010 updated by: Actelion

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

132

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (ACTUAL)

September 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

October 6, 2003

First Submitted That Met QC Criteria

October 7, 2003

First Posted (ESTIMATE)

October 8, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-052-330
  • BUILD 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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