Open-label Study With Bosentan in Interstitial Lung Disease

Phase 3CompletedNCT00319033

Actelion132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Interstitial Lung Disease Scleroderma

Interventions

bosentanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from baseline to all assessed time points in 6-minute walk test distance.

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).

Transition Dyspnea Index at all assessed time points.

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.

Secondary Outcomes

Adverse events; serious adverse events.

Data from ClinicalTrials.gov

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