Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00403650
First received: November 24, 2006
Last updated: April 10, 2013
Last verified: April 2013

November 24, 2006
April 10, 2013
November 2006
July 2008   (final data collection date for primary outcome measure)
Change in six minute walk distance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Six minute walk distance
Complete list of historical versions of study NCT00403650 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Respiratory function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Pulmonary artery hemodynamics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of life
  • Respiratory function
  • Toxicity
  • Pulmonary artery hemodynamics
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00403650
Sarcoid 6
No
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