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Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

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ClinicalTrials.gov 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.

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
Primary Completion Date : July 2008
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 ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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 ClinicalTrials.gov identifier (NCT number): NCT00403650

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Robert P. Baughman, MD University of Cincinnati

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00403650     History of Changes
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:
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents