NCT00109681

Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis

A Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Pilot Efficacy of Iloprost Inhalation Solution in Adults With Abnormal Pulmonary Arterial Pressure and Exercise Limitation Associated With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with idiopathic pulmonary fibrosis (IPF) and elevated pulmonary arterial pressure. The secondary purpose is to evaluate the effectiveness of this treatment in subjects with this disease.

Detailed description

While there are no FDA approved therapies for the treatment of IPF, there are therapies that have been shown to be effective in ameliorating the effects of pulmonary hypertension in patients with PAH (pulmonary arterial hypertension), including inhaled iloprost. However, these therapies have not been used extensively in patients with IPF who have pulmonary hypertension as a complication. The potential benefits of treatment of pulmonary hypertension complicating IPF include: improvement in pulmonary hemodynamics, with reduction in pulmonary artery pressure and pulmonary vascular resistance, and increase in cardiac output.

Conditions

• Pulmonary Fibrosis
• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Iloprost Inhalation Solution (Ventavis)

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2005-05-03
• Last updated: 2010-02-15

Locations

17 sites across 1 country: United States