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OpenTrials
Completed

NCT Number: NCT00109681

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

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.

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Key information

Conditions

Pulmonary Fibrosis Behavior Cardiovascular Diseases Fibrosis Hypertension Hypertension, Pulmonary Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Arterial Hypertension Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iloprost Inhalation Solution (Ventavis)

Drug

Primary outcomes

  1. Safety

Secondary outcomes

  1. 6 minute walk distance

  2. exercise associated oxygen desaturation

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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)

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 3, 2005
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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