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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
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Dyspnea, Interstitial lung disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 24, 2006
Last Updated
April 10, 2013
Sponsor
University of Cincinnati
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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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