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

This study has been completed.
Information provided by:
Actelion Identifier:
First received: October 6, 2003
Last updated: February 11, 2010
Last verified: February 2010
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
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

Resource links provided by NLM:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
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Please refer to this study by its identifier: NCT00070590

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  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00070590     History of Changes
Other Study ID Numbers: AC-052-330
Study First Received: October 6, 2003
Last Updated: February 11, 2010

Keywords provided by Actelion:
Fibrosing alveolitis

Additional relevant MeSH terms:
Pulmonary Fibrosis
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017