Open-Label Study With Bosentan in Interstitial Lung Disease - Full Text View

Sponsored by:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00319033

Purpose

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

Condition	Intervention	Phase
Interstitial Lung Disease Scleroderma	Drug: bosentan	Phase II Phase III

Drug Information available for: Bosentan

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Open-Label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

Further study details as provided by Actelion:

Primary Outcome Measures:

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 Outcome Measures:

Estimated Enrollment:	132
Study Start Date:	July 2004
Estimated Study Completion Date:	February 2006

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319033

Sponsors and Collaborators

Actelion

More Information

Study ID Numbers:	AC-052-332, BUILD 2 OL
Study First Received:	April 26, 2006
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00319033
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

interstitial lung disease
scleroderma
bosentan

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Lung Diseases

Sclerosis
Scleroderma, Systemic
Bosentan

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009