Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled treprostinil	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	73 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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.
Study Start Date :	September 2008
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Number of Adverse Events [ Time Frame: up to 24 months ]
   Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.

Secondary Outcome Measures :

1. Six-minute Walk Distance (6MWD) [ Time Frame: Baseline and 12 weeks ]
   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.
2. Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [ Time Frame: Baseline and 12 weeks ]
   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.
3. Treatment Satisfaction Questionnaire of Medication (TSQM) [ Time Frame: Baseline and 12 weeks ]
   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.
4. Patient Impression of Change [ Time Frame: Baseline and 12 weeks ]
   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.
5. N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline and Week 12 ]
   Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.
6. World Health Organization (WHO) Functional Class [ Time Frame: Baseline and 12 Weeks ]
   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.
7. Drug Administration Activities Questionnaire [ Time Frame: Baseline and 12 weeks ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Nursing or pregnant
• Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
• History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
• Use of investigational drug within 30 days of Baseline

Contacts and Locations

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Locations

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
Beth Israel Medical Center
New York City, New York, United States, 10003-3314
Cornell University Medical Center
New York City, New York, United States, 10021
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
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
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

United Therapeutics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00741819 History of Changes
Other Study ID Numbers:	RIN-PH-401
First Posted:	August 26, 2008
Results First Posted:	February 20, 2013
Last Update Posted:	February 20, 2013
Last Verified:	January 2013

Keywords provided by United Therapeutics:

pulmonary arterial hypertension; PAH; treprostinil sodium	inhalation; ventavis; iloprost

Additional relevant MeSH terms:

Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases	Respiratory Tract Diseases; Treprostinil; Iloprost; Antihypertensive Agents; Platelet Aggregation Inhibitors; Vasodilator Agents