Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Number of Adverse Events [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.
- Six-minute Walk Distance (6MWD) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10-30 minutes following the last dose of inhaled iloprost) and at Week 12 (10-60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.
- Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.
- Treatment Satisfaction Questionnaire of Medication (TSQM) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject's satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject's satisfaction with inhaled treprostinil.
- Patient Impression of Change [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.
- N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.
- World Health Organization (WHO) Functional Class [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.
- Drug Administration Activities Questionnaire [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).
|Study Start Date:||September 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Inhaled treprostinil
Solution 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.
Drug: Inhaled treprostinil
Other Name: Tyvaso
|United States, Alabama|
|University of Alabama Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCSD Medical Center|
|La Jolla, California, United States, 82037|
|Ronald Reagan UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, New York|
|Long Island Jewish Medical Center - North Shore|
|New Hyde Park, New York, United States, 11040|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|Cornell University Medical Center|
|New York City, New York, United States, 10021|
|Beth Israel Medical Center|
|New York City, New York, United States, 10003-3314|
|Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care|
|Rochester, New York, United States, 14623|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pittsburg Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|