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

Primary Purpose

Pulmonary Fibrosis, Scleroderma, Systemic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bosentan
Sponsored by
Actelion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Scleroderma, Fibrosing alveolitis, Build, bosentan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA Med School
  • Denver Health Medical Center
  • Georgetown University
  • Jackson Memorial Hospital
  • University of Illinois College of Medicine
  • Boston Univ School of Medicine
  • UMDNJ
  • The Center for Rheumatology
  • The Cleveland Clinic
  • Thomas Jefferson University
  • University of Pittsburgh
  • Medical Univ of South Carolina
  • University of Texas Houston Medical School
  • Virginia Mason Medical Center
  • University of Washington
  • Centre Hospitalier Universitaire
  • CHRU Claude Huriez
  • Hôpital Cochin
  • Hôpital Saint Antoine
  • Charité Universitätsklinikum
  • Rabin Medical Center
  • Instituto di Clinica, Villa Monna Tessa
  • Ospedale Maggiore
  • Policlinico Universitario
  • Sint Maartenskliniek
  • University Hospital
  • University Hospital
  • General Infirmary
  • Royal Free Hospital

Outcomes

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

Full Information

First Posted
October 6, 2003
Last Updated
February 11, 2010
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00070590
Brief Title
Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Scleroderma, Systemic
Keywords
Scleroderma, Fibrosing alveolitis, Build, bosentan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
132 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bosentan
Primary Outcome Measure Information:
Title
Change from baseline to End-of-Study in 6-minute walk distance.
Secondary Outcome Measure Information:
Title
Time to death (all causes) or to worsening of PFTs up to End-of-Study.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
UCLA Med School
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Illinois College of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston Univ School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
UMDNJ
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15267
Country
United States
Facility Name
Medical Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Centre Hospitalier Universitaire
City
Grenoble
Country
France
Facility Name
CHRU Claude Huriez
City
Lille
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
Charité Universitätsklinikum
City
Berlin
Country
Germany
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Instituto di Clinica, Villa Monna Tessa
City
Firenze
Country
Italy
Facility Name
Ospedale Maggiore
City
Milano
Country
Italy
Facility Name
Policlinico Universitario
City
Padova
Country
Italy
Facility Name
Sint Maartenskliniek
City
Nijmegen
Country
Netherlands
Facility Name
University Hospital
City
Lund
Country
Sweden
Facility Name
University Hospital
City
Zurich
Country
Switzerland
Facility Name
General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33765691
Citation
Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6.
Results Reference
derived
PubMed Identifier
20506355
Citation
Seibold JR, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells A, Matucci Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM. Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Arthritis Rheum. 2010 Jul;62(7):2101-8. doi: 10.1002/art.27466. Erratum In: Arthritis Rheum. 2010 Oct;62(10):3005.
Results Reference
derived

Learn more about this trial

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

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