Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.
1 other identifier
interventional
73
1 country
15
Brief Summary
This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis). Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Typical duration for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
February 20, 2013
CompletedFebruary 20, 2013
January 1, 2013
1.5 years
August 23, 2008
May 17, 2012
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.
up to 24 months
Secondary Outcomes (7)
Six-minute Walk Distance (6MWD)
Baseline and 12 weeks
Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Baseline and 12 weeks
Treatment Satisfaction Questionnaire of Medication (TSQM)
Baseline and 12 weeks
Patient Impression of Change
Baseline and 12 weeks
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)
Baseline and Week 12
- +2 more secondary outcomes
Study Arms (1)
Inhaled treprostinil
EXPERIMENTALSolution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.
Interventions
Eligibility Criteria
You may qualify if:
- Between 18 and 75 years of age
- PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired \>/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
- Baseline six-minute walk distance (6MWD) \>/= 250 meters
- Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
- If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
- Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH
You may not qualify if:
- Nursing or pregnant
- History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
- Use of investigational drug within 30 days of Baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
UCSD Medical Center
La Jolla, California, 82037, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Long Island Jewish Medical Center - North Shore
New Hyde Park, New York, 11040, United States
Beth Israel Medical Center
New York, New York, 10003-3314, United States
Cornell University Medical Center
New York, New York, 10021, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care
Rochester, New York, 14623, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small, open-label study without comparison arm.
Results Point of Contact
- Title
- Inhaled Treprostinil Program Head
- Organization
- United Therpaeutics Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2008
First Posted
August 26, 2008
Study Start
September 1, 2008
Primary Completion
March 1, 2010
Study Completion
December 1, 2010
Last Updated
February 20, 2013
Results First Posted
February 20, 2013
Record last verified: 2013-01