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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00070590
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : February 15, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Scleroderma, Systemic Drug: Bosentan Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

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

Secondary Outcome Measures :
  1. Time to death (all causes) or to worsening of PFTs up to End-of-Study.
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00070590

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Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00070590    
Other Study ID Numbers: AC-052-330
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Keywords provided by Actelion:
Fibrosing alveolitis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action