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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00109681

Enrollment

Registered

2005-05-03

Start date

2005-04-30

Completion date

2006-10-31

Last updated

2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis, Pulmonary Hypertension

Keywords

ACTIVE, iloprost, idiopathic pulmonary fibrosis, pulmonary arterial hypertension

Brief 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.

Interventions

DRUGIloprost Inhalation Solution (Ventavis)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
6 minute walk distance	—
exercise associated oxygen desaturation	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026