Open-label Study With Bosentan in Interstitial Lung Disease

Phase 2

Completed

• Conditions: Scleroderma; Interstitial Lung Disease

• Registration Number: NCT00319033
• Lead Sponsor: Actelion

Brief Summary

This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-04-26
• Study First Submitted QC: 2006-04-26
• Study First Posted: 2006-04-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• To have completed the 12-month treatment period of the AC-052-330/BUILD 2.
• Women should not be pregnant
• Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception
• Signed informed consent prior to initiation of any study-mandated procedure

Exclusion Criteria

• Any major violation of the protocol AC-052-330.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline to all assessed time points in 6-minute walk test distance.
Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test.
Transition Dyspnea Index at all assessed time points.
Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).

Secondary Outcome Measures

Name	Time	Method
Adverse events; serious adverse events.

Trial Locations

Locations (35)

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Maureen Mayes, MD; 🇺🇸 Houston, Texas, United States

Ospedale Maggiore; 🇮🇹 Milano, Italy

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Medical Univ of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Eric Rich, MD; 🇨🇦 Montreal, Quebec, Canada

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States

UCLA Med School; 🇺🇸 Los Angeles, California, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

University of Illinois College of Medicine; 🇺🇸 Chicago, Illinois, United States

University of Michigan Health System - Division of Pulmonary & Critical Care Medicine; 🇺🇸 Ann Arbor, Michigan, United States

UMDNJ; 🇺🇸 New Brunswick, New Jersey, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

University of Washington - Division of Pulmonary & Critical Care Medicine; 🇺🇸 Seattle, Washington, United States

CHRU Claude Huriez; 🇫🇷 Lille, France

Centre Hospitalier Universitaire; 🇫🇷 Grenoble, France

Charité Universitätsklinikum; 🇩🇪 Berlin, Germany

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel

Instituto di Clinica, Villa Monna Tessa; 🇮🇹 Firenze, Italy

Policlinico Universitario; 🇮🇹 Padova, Italy

SoonChunHyang University Bucheon Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

7003 - Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Royal Free Hospital; 🇬🇧 London, United Kingdom

University Hospital; 🇨🇭 Zurich, Switzerland

Sint Maartenskliniek; 🇳🇱 Nijmegen, Netherlands

General Infirmary; 🇬🇧 Leeds, United Kingdom

Lee Shapiro, MD; 🇺🇸 Albany, New York, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States