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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070590

  Show 29 Study Locations
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 August 19, 2014