Interstitial Lung DiseasePhase 2/3BUILD 2 OLNCT00319033
Open-label Study With Bosentan in Interstitial Lung Disease
A Phase 2/3 study testing bosentan in people with Interstitial Lung Disease and Scleroderma, run by Actelion.
Trial summary
This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Scleroderma
- What is being tested?
- bosentan
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any major violation of the protocol AC-052-330.
About this 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.
This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.
- Conditions
- Interstitial Lung Disease, Scleroderma
- Being tested
- bosentan
- Keywords
- interstitial lung disease, scleroderma, bosentan
- Medical subject headings
- Lung Diseases, Interstitial, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Adverse events; serious adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startJul 2004
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319033
- Sponsor's protocol ID
- AC-052-332
- Other IDs
- BUILD 2 OL
- Acronym
- BUILD 2 OL
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2006
- Last updated
- 3 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.
- ClinicalTrials.gov ID
- NCT00319033
- Acronym / sponsor ID
- BUILD 2 OL / AC-052-332
- Conditions
- Interstitial Lung Disease, Scleroderma
- Keywords
- interstitial lung disease, scleroderma, bosentan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any major violation of the protocol AC-052-330.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bosentan | Drug | – |
Primary outcome
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.
1 secondary outcome
Adverse events; serious adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bosentan in people with Interstitial Lung Disease and Scleroderma, run by Actelion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to all assessed time points in 6-minute walk test distance.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.