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Open-label Study With Bosentan in Interstitial Lung Disease (BUILD 2 OL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319033
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 30, 2015
Information provided by:

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

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Scleroderma Drug: bosentan Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.
Study Start Date : July 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Primary Outcome Measures :
  1. Change from baseline to all assessed time points in 6-minute walk test distance.
  2. 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).
  3. Transition Dyspnea Index at all assessed time points.
  4. 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 :
  1. Adverse events; serious adverse events.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00319033

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Sponsors and Collaborators

Layout table for additonal information Identifier: NCT00319033    
Other Study ID Numbers: AC-052-332
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by Actelion:
interstitial lung disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Scleroderma, Systemic
Scleroderma, Diffuse
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action