Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
Primary Purpose
Sarcoidosis, Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Iloprost
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Dyspnea, Interstitial lung disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change in six minute walk distance
Secondary Outcome Measures
Quality of life
Respiratory function
Toxicity
Pulmonary artery hemodynamics
Full Information
NCT ID
NCT00403650
First Posted
November 24, 2006
Last Updated
April 10, 2013
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00403650
Brief Title
Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
Official Title
Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary Arterial Hypertension
Keywords
Sarcoidosis, Dyspnea, Interstitial lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Iloprost
Other Intervention Name(s)
Ventavis
Intervention Description
Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
Primary Outcome Measure Information:
Title
Change in six minute walk distance
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
24 weeks
Title
Respiratory function
Time Frame
24 weeks
Title
Toxicity
Time Frame
24 weeks
Title
Pulmonary artery hemodynamics
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P. Baughman, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20560291
Citation
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.
Results Reference
derived
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Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
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