Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma - Full Text View

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 II Phase III

MedlinePlus related topics:

Pulmonary Fibrosis Scleroderma

Drug Information available for:

Bosentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	September 2005

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

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

Show 29 Study Locations

Sponsors and Collaborators

Actelion

More Information

Study ID Numbers:	AC-052-330, BUILD 2
First Received:	October 6, 2003
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00070590
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

Scleroderma

Fibrosing alveolitis

Build

bosentan

Study placed in the following topic categories:

Lung Diseases, Interstitial

Skin Diseases

Respiratory Tract Diseases

Fibrosis

Hamman-Rich syndrome

Lung Diseases

Connective Tissue Diseases

Sclerosis

Scleroderma, Systemic

Fibrosing alveolitis

Pulmonary Fibrosis

Bosentan

Additional relevant MeSH terms:

Pathologic Processes

Therapeutic Uses

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00070590