Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension - Full Text View

Purpose

Treatment of sarcoidosis associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension

Condition	Intervention	Phase
Sarcoidosis Pulmonary Arterial Hypertension	Drug: Iloprost	Phase IV

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure Pulmonary Hypertension Sarcoidosis

ChemIDplus related topics:

Iloprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:

Change in six minute walk distance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Iloprost Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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) n 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 on survival during the course of the study.
Patients unable to perform the 6 inhalation treatments required for therapy.
Patients with < 90 mmHg Systolic systemic blood pressure will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403650

Contacts


Contact: Robert P Baughman, MD	513-584-5225	bob.baughman@uc.edu

Contact: Stacy Harman	513-584-6252

Locations


United States, Ohio
	University of Cincinnati	Recruiting
	Cincinnati, Ohio, United States, 45267
	Contact: Bobbie Morgan 513-584-6252
	Principal Investigator: Robert P Baughman, MD

Sponsors and Collaborators

University of Cincinnati

Investigators


Principal Investigator:	Robert P Baughman, MD	University of Cincinnati

More Information

Responsible Party:	University of Cincinnati ( Robert P. Baughman MD )
Study ID Numbers:	Sarcoid 6
First Received:	November 24, 2006
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00403650
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Cincinnati:

Sarcoidosis

Dyspnea

Interstitial lung disease

Study placed in the following topic categories:

Idiopathic pulmonary hypertension

Iloprost

Lymphatic Diseases

Lung Diseases, Interstitial

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Vascular Diseases

Sarcoidosis

Lymphoproliferative Disorders

Dyspnea

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Therapeutic Uses

Hematologic Agents

Platelet Aggregation Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University of Cincinnati
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00403650