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

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Fibrosis; Scleroderma, Systemic

Intervention: Bosentan (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Actelion

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Centre Hospitalier Universitaire, Grenoble, France

CHRU Claude Huriez, Lille, France

Hôpital Cochin, Paris, France

Hôpital Saint Antoine, Paris, France

Charité Universitätsklinikum, Berlin, Germany

Rabin Medical Center, Petach Tikva, Israel

Instituto di Clinica, Villa Monna Tessa, Firenze, Italy

Ospedale Maggiore, Milano, Italy

Policlinico Universitario, Padova, Italy

Sint Maartenskliniek, Nijmegen, Netherlands

University Hospital, Lund, Sweden

University Hospital, Zurich, Switzerland

General Infirmary, Leeds, United Kingdom

Royal Free Hospital, London, United Kingdom

UCLA Med School, Los Angeles, California 90095, United States

Denver Health Medical Center, Denver, Colorado 80204, United States

Georgetown University, Washington, District of Columbia 20007, United States

Jackson Memorial Hospital, Miami, Florida 33136, United States

University of Illinois College of Medicine, Chicago, Illinois 60612, United States

Boston Univ School of Medicine, Boston, Massachusetts 02118, United States

UMDNJ, New Brunswick, New Jersey 08903, United States

The Center for Rheumatology, Albany, New York 12206, United States

The Cleveland Clinic, Cleveland, Ohio 44195, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19004, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15267, United States

Medical Univ of South Carolina, Charleston, South Carolina 29425, United States

University of Texas Houston Medical School, Houston, Texas 77030, United States

University of Washington, Seattle, Washington 98195, United States

Virginia Mason Medical Center, Seattle, Washington 98101, United States

Additional Information

Starting date: July 2003
Last updated: February 11, 2010

Page last updated: August 23, 2015

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