Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109681
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2005-05-02
Brief Title:
Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None