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

This study has been completed.
Information provided by:
Actelion Identifier:
First received: April 26, 2006
Last updated: April 28, 2015
Last verified: April 2015
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 2 Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

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:
  • Adverse events; serious adverse events.

Estimated Enrollment: 132
Study Start Date: July 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00319033

  Show 36 Study Locations
Sponsors and Collaborators
  More Information Identifier: NCT00319033     History of Changes
Other Study ID Numbers: AC-052-332
Study First Received: April 26, 2006
Last Updated: April 28, 2015

Keywords provided by Actelion:
interstitial lung disease

Additional relevant MeSH terms:
Lung Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases, Interstitial
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017