Overview

Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Cincinnati
Treatments:
Iloprost
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) 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