SarcoidosisPhase 4NCT00403650
Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
A Phase 4 study testing Iloprost in people with Sarcoidosis and Pulmonary Arterial Hypertension, run by University of Cincinnati at 1 site in United States.
Trial summary
This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoidosis, Pulmonary Arterial Hypertension
- What is being tested?
- Iloprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2008
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known sarcoidosis 17
- Age 18 or greater
- Patients with documented pulmonary hypertension with a PA mean > 25 mm as measured by cardiac catheterization within six months of entry into the study
- Patients with dyspnea
- 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) in 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%
- Significant liver dysfunction not due to sarcoidosis
Show all 9Show fewer
- Patients with severe other organ disease felt by investigators to impact survival during the course of the study
- Patients unable to perform the 6 inhalation treatments required for therapy
- Patients with < 90 mm Hg Systolic systemic blood pressure will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension
This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
Read the detailed description
Pulmonary hypertension has been described in sarcoidosis. It can be a significant problem, not responsive to treatment with anti-inflammatory drugs for the sarcoidosis (1;2). Inhaled iloprost has been approved for treatment of pulmonary hypertension (3). We propose to study the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension (SAPAH). This is an open label trial, with patients receiving 16 weeks of therapy. Clinical and hemodynamic outcome of therapy will be assessed.
- Conditions
- Sarcoidosis, Pulmonary Arterial Hypertension
- Being tested
- Iloprost
- Keywords
- Sarcoidosis, Dyspnea, Interstitial lung disease
- Medical subject headings
- Sarcoidosis, Pulmonary Arterial Hypertension, Dyspnea, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
Also called Ventavis
Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Iloprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six minute walk distance
Measured: 24 weeks
Secondary outcomes (4)
Quality of life
Measured: 24 weeks
Respiratory function
Measured: 24 weeks
Toxicity
Measured: 24 weeks
Pulmonary artery hemodynamics
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2008
- Study completionSep 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- 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
- NCT00403650
- Sponsor's protocol ID
- Sarcoid 6
- Status last verified
- Apr 2013
- First submitted
- 24 Nov 2006
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Baughman RP, Judson MA, Lower EE, Highland K, Kwon S, Craft N, Engel PJ. Inhaled iloprost for sarcoidosis associated pulmonary hypertension. Sarcoidosis Vasc Diffuse Lung Dis. 2009 Jul;26(2):110-20.
PubMed 20560291
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
- Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00403650
- Acronym / sponsor ID
- Sarcoid 6
- Conditions
- Sarcoidosis, Pulmonary Arterial Hypertension
- Keywords
- Sarcoidosis, Dyspnea, Interstitial lung disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 27 Nov 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 trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
Detailed description
Pulmonary hypertension has been described in sarcoidosis. It can be a significant problem, not responsive to treatment with anti-inflammatory drugs for the sarcoidosis (1;2). Inhaled iloprost has been approved for treatment of pulmonary hypertension (3). We propose to study the effectiveness of inhaled iloprost for sarcoidosis associated pulmonary hypertension (SAPAH). This is an open label trial, with patients receiving 16 weeks of therapy. Clinical and hemodynamic outcome of therapy will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Iloprost |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with known sarcoidosis 17
- Age 18 or greater
- Patients with documented pulmonary hypertension with a PA mean > 25 mm as measured by cardiac catheterization within six months of entry into the study
- Patients with dyspnea
- Six minute walk distance of between 100 to 500 meters
Key exclusion criteria (9 listed)
- Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in 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 |
|---|---|---|
| IloprostAlso: VentavisIloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day | Drug | 1 |
Primary outcome
Change in six minute walk distance
Time frame: 24 weeks
4 secondary outcomes
Quality of life
Time frame: 24 weeks
Respiratory function
Time frame: 24 weeks
Toxicity
Time frame: 24 weeks
Pulmonary artery hemodynamics
Time frame: 24 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 20560291Baughman RP, Judson MA, Lower EE, Highland K, Kwon S, Craft N, Engel PJ. Inhaled iloprost for sarcoidosis associated pulmonary hypertension. Sarcoidosis Vasc Diffuse Lung Dis. 2009 Jul;26(2):110-20.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iloprost in people with Sarcoidosis and Pulmonary Arterial Hypertension, run by University of Cincinnati at 1 site 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 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in six minute walk distance (time frame: 24 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 NCT00403650, 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.