Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403650
• Other study ID #: Sarcoid 6
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2006
• Last updated: April 10, 2013
• Start date: November 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This trial will study the treatment of sarcoidosis-associated pulmonary arterial hypertension with inhaled iloprost, a drug approved for primary pulmonary arterial hypertension.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Sarcoidosis

Intervention

Drug:
• Iloprost
Iloprost 2.5-5 mg inhaled via nebulizer up to 6 times a day

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six minute walk distance		24 weeks	No
Secondary	Quality of life		24 weeks	Yes
Secondary	Respiratory function		24 weeks	No
Secondary	Toxicity		24 weeks	Yes
Secondary	Pulmonary artery hemodynamics		24 weeks	No