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

November 24, 2006
November 27, 2006
April 12, 2013
November 2006
July 2008   (Final data collection date for primary outcome measure)
Change in six minute walk distance [ Time Frame: 24 weeks ]
Six minute walk distance
Complete list of historical versions of study NCT00403650 on Archive Site
  • 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 ]
  • Quality of life
  • Respiratory function
  • Toxicity
  • Pulmonary artery hemodynamics
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Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension
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.
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.
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Sarcoidosis
  • Pulmonary Arterial Hypertension
Drug: Iloprost
Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day
Other Name: Ventavis
Experimental: 1
Intervention: Drug: Iloprost
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Sarcoid 6
Not Provided
Not Provided
Robert P Baughman, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Robert P. Baughman, MD University of Cincinnati
University of Cincinnati
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP