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Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403650
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Sarcoidosis Pulmonary Arterial Hypertension Drug: Iloprost Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension
Study Start Date : November 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: 1 Drug: Iloprost
Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
Other Name: Ventavis

Primary Outcome Measures :
  1. Change in six minute walk distance [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 24 weeks ]
  2. Respiratory function [ Time Frame: 24 weeks ]
  3. Toxicity [ Time Frame: 24 weeks ]
  4. Pulmonary artery hemodynamics [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403650

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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
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Principal Investigator: Robert P. Baughman, MD University of Cincinnati
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati Identifier: NCT00403650    
Other Study ID Numbers: Sarcoid 6
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013
Keywords provided by Robert P Baughman, University of Cincinnati:
Interstitial lung disease
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents