SarcoidosisPhase 2/3BOSAPAHNCT00581607
Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
A Phase 2/3 study testing Bosentan in people with Sarcoidosis and Pulmonary Arterial Hypertension, run by University of Cincinnati at 4 sites in United States.
Trial summary
Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary Arterial Hypertension
- What is being tested?
- Bosentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2008to Dec 2012
- 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
- Patients with known sarcoidosis 21.
- Age 18 or greater
- Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.
- Patients with WHO class II or III
- Six minute walk distance of between 100 to 500 meters
- Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
- Patients able to provide written consent
Who cannot join
- Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
- Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
- Patients with World Health Organization (WHO) class IV status.
- Patients who are pregnant or breast feeding
- Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
- Cardiac index < 2.0 liters and/or right atrial pressure >15 mm Hg
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- Significant liver dysfunction not due to sarcoidosis.
- Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
- Patients unable to perform the 6 minute walk study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio
Mount Sinai
New York, New York
University of Pittsburgh
Pittsburgh, Pennsylvania
About this study
Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.
Read the detailed description
Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.
- Conditions
- Sarcoidosis, Pulmonary Arterial Hypertension
- Being tested
- Bosentan, Placebo
- Keywords
- Sarcoidosis
- Medical subject headings
- Sarcoidosis, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called Tracleer
62.5 mg bid for 4 weeks, then 125 mg bid
PlaceboDrug
Placebo twice a day
BosentanDrug
Also called tracleer
drug given for 16 weeks
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Bosentan for 16 weeks | Active comparator | Active drug Receives: Drug: Bosentan |
| Placebo | Placebo comparator | Placebo for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in six minute walk distance
Measured: 16 weeks
Secondary outcomes (3)
Change in pulmonary hemodynamics
Measured: 16 weeks
Improvement in quality of life with therapy
Measured: 48 weeks
Safety of treatment
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startApr 2008
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert P Baughman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581607
- Sponsor's protocol ID
- BOSAPAH-1
- Other IDs
- 7-3-22-1
- Acronym
- BOSAPAH
- Status last verified
- Apr 2013
- First submitted
- 26 Dec 2007
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baughman RP, Culver DA, Cordova FC, Padilla M, Gibson KF, Lower EE, Engel PJ. Bosentan for sarcoidosis-associated pulmonary hypertension: a double-blind placebo controlled randomized trial. Chest. 2014 Apr;145(4):810-817. doi: 10.1378/chest.13-1766.
PubMed 24177203
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00581607
- Acronym / sponsor ID
- BOSAPAH / BOSAPAH-1
- Conditions
- Sarcoidosis, Pulmonary Arterial Hypertension
- Keywords
- Sarcoidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- Apr 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Dec 2007 (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.
Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.
Detailed description
Patients will be randomized in 2:1 manner to receive either bosentan or placebo for 16 weeks. After 16 weeks, there will be an additional 32 weeks of an open label extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan for 16 weeks | Active comparator | Drug: BosentanActive drug |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with known sarcoidosis 21.
- Age 18 or greater
- Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg.
- Patients with WHO class II or III
- Six minute walk distance of between 100 to 500 meters
Key exclusion criteria (9 listed)
- Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker.
- Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
- Patients with World Health Organization (WHO) class IV status.
- Patients who are pregnant or breast feeding
- Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
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 |
|---|---|---|
| BosentanAlso: Tracleer62.5 mg bid for 4 weeks, then 125 mg bid | Drug | Bosentan for 16 weeks |
| PlaceboPlacebo twice a day | Drug | Placebo |
| BosentanAlso: tracleerdrug given for 16 weeks | Drug | Bosentan for 16 weeks |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Improvement in six minute walk distance
Time frame: 16 weeks
3 secondary outcomes
Change in pulmonary hemodynamics
Time frame: 16 weeks
Improvement in quality of life with therapy
Time frame: 48 weeks
Safety of treatment
Time frame: 48 weeks
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 12 Apr 2013.
- Derived from this study: PubMed 24177203Baughman RP, Culver DA, Cordova FC, Padilla M, Gibson KF, Lower EE, Engel PJ. Bosentan for sarcoidosis-associated pulmonary hypertension: a double-blind placebo controlled randomized trial. Chest. 2014 Apr;145(4):810-817. doi: 10.1378/chest.13-1766.
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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.
Robert P Baughman, MD principal investigator
University of Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bosentan in people with Sarcoidosis and Pulmonary Arterial Hypertension, run by University of Cincinnati at 4 sites in United States.
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 7 inclusion and 9 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 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Improvement in six minute walk distance (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00581607, which also lists 1 linked publication.
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 12 Apr 2013.