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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00741819
First received: August 23, 2008
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
 Drug: Inhaled treprostinil
 Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 73
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741819

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
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
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT00741819     History of Changes
Other Study ID Numbers: RIN-PH-401
Study First Received: August 23, 2008
Results First Received: May 17, 2012
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
pulmonary arterial hypertension
PAH
treprostinil sodium
 inhalation
ventavis
iloprost

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Treprostinil
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013