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.