Clinical trial NCT00109681: Inhaled Iloprost in Adults With Abnormal Pulmonary Pressure and Associated With Idiopathic Pulmonary Fibrosis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Fibrosis
Pulmonary Hypertension
Keywords: ACTIVE
iloprost
idiopathic pulmonary fibrosis
pulmonary arterial hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2005-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: 6 minute walk distance
measure: exercise associated oxygen desaturation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa College of Medicine
state: Iowa
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler
state: Texas
city: Church Falls
country: United States
facility: Inova Research Center
state: Virginia
Study officials:
affiliation: CoTherix
name: James Pennington, MD
role: STUDY_DIRECTOR
References: