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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Pulmonary Fibrosis, Pulmonary Hypertension

Intervention / Treatment
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* Drug: Iloprost Inhalation Solution (Ventavis)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria Diagnosis of elevated pulmonary pressures Six minute walk distance between 50-380 NYHA functional class II - IV Exclusion Criteria: Pulmonary fibrosis related to a systemic disorder Significant chronic obstructive pulmonary disease History of thromboembolic disease within the previous year Awaiting lung transplantation within next 36 weeks Active lung infection Survival prognosis of less than 1 year Significant left-sided heart failure, active coronary artery disease Clinically relevant liver disease Concurrent medications: epoprostenol, treprostinil, bosentan, PDE-5 inhibitor, investigational agents

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iloprost Inhalation Solution (Ventavis)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance |  |  | 
| exercise associated oxygen desaturation |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension