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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pulmonary Fibrosis
- Sponsor
- Actelion
- Enrollment
- 50
- Locations
- 17
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Safety
Secondary Outcomes
- 6 minute walk distance
- exercise associated oxygen desaturation