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Epinephrine Inhalation Solution |
Adrenalin |
Clinical Trial: Inhaled Iloprost in Adults with Abnormal Pulmonary Pressure and Associated with Idiopathic Pulmonary Fibrosis
This study is currently recruiting patients.
|
Purpose
The primary purpose of this study is to determine whether iloprost inhalation solution is safe in subjects with mild to moderate 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Pulmonary Fibrosis Pulmonary Hypertension | Drug: Iloprost Inhalation Solution (Ventavis) | Phase II |
MedlinePlus related topics: Pulmonary Fibrosis; Pulmonary Hypertension
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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 Mild-to-moderate Idiopathic Pulmonary Fibrosis
Secondary Outcomes: 6 minute walk distance; exercise associated oxygen desaturation; hemodynamic parameters
Expected Total Enrollment: 50
Study start: April 2005; Expected completion: November 2006
Last follow-up: June 2006; Data entry closure: August 2006
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
Ages Eligible for Study: 40 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Diagnosis of idiopathic pulmonary fibrosis according to American Thoracic Society criteria
- Diagnosis of pulmonary arterial hypertension
- Six minute walk distance between 100-380
- 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
Location and Contact Information
Scott Giles 650-808-6511 sgiles@cotherix.com
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States; Not yet recruiting
Joao A. de Andrade, MD, Principal Investigator
California
University of California at Davis, Davis, California, 95817, United States; Not yet recruiting
Andrew Chan, MD, Principal Investigator
University of California, San Francisco, San Francisco, California, 94143, United States; Not yet recruiting
Carla Teehankee 415-353-1807 teehankee@medicine.ucsf.edu
Jeffrey A. Golden, MD, Principal Investigator
Teresa De Marco, MD, Principal Investigator
University of California, San Diego, San Diego, California, 92037, United States; Not yet recruiting
Gordon Yung, MD, Principal Investigator
UCLA School of Medicine, Los Angeles, California, 90095, United States; Not yet recruiting
David A. Zisman, MD, Principal Investigator
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520, United States; Not yet recruiting
John McArdle, MD, Principal Investigator
Florida
University of Miami, Miami, Florida, 33136, United States; Not yet recruiting
Marilyn Glassberg, MD, Principal Investigator
Illinois
The University of Chicago, Chicago, Illinois, 60637, United States; Not yet recruiting
Imre Noth, MD, Principal Investigator
Michigan
University of Michigan Health System, Ann Arbor, Michigan, 48109, United States; Not yet recruiting
Kevin R. Flaherty, MD, Principal Investigator
Minnesota
Mayo Clinic Rochester, Rochester, Minnesota, 55905, United States; Not yet recruiting
Michael Krowka, MD, Principal Investigator
New York
Mount Sinai Medical Center, New York, New York, 10029, United States; Not yet recruiting
Maria Padilla, MD, Principal Investigator
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States; Not yet recruiting
Victor Tapson, MD, Principal Investigator
Pennsylvania
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, 15213, United States; Not yet recruiting
Srinivas Murali, MD, Principal Investigator
Tennessee
Vanderbilt University Medical, Nashville, Tennessee, 37232, United States; Not yet recruiting
Lisa Lancaster, MD, Principal Investigator
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Not yet recruiting
Adaani Frost, MD, Principal Investigator
University of Texas Health Center at Tyler, Tyler, Texas, 75708, United States; Recruiting
James Stocks, MD, Principal Investigator
Virginia
Inova Research Center, Church Falls, Virginia, 22042, United States; Not yet recruiting
Shahzad Ahmad, MD, Principal Investigator
Henry Hsu, MD, Study Director, CoTherix
More Information
Record last reviewed: April 2005
Last Updated: May 2, 2005
Record first received: May 2, 2005
ClinicalTrials.gov Identifier: NCT00109681
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005
Resources
- Adrenalin (Drug Digest)
- Epinephrine Inhalation Solution (Drug Digest)
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