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

Actelion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Pulmonary Fibrosis

Pulmonary Hypertension

Treatments

Drug: Iloprost Inhalation Solution (Ventavis)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109681

ACTIVE C200-003

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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