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

Pulmonary Arterial Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741819
• Other study ID #: RIN-PH-401
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2008
• Last updated: January 16, 2013
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Inhaled treprostinil

Locations

Country	Name	City	State
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	UCSD Medical Center	La Jolla	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Long Island Jewish Medical Center - North Shore	New Hyde Park	New York
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Beth Israel Medical Center	New York City	New York
United States	Cornell University Medical Center	New York City	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania
United States	Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Six-minute Walk Distance (6MWD)	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.	Baseline and 12 weeks	No
Secondary	Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)	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.	Baseline and 12 weeks	No
Secondary	Treatment Satisfaction Questionnaire of Medication (TSQM)	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.	Baseline and 12 weeks	No
Secondary	Patient Impression of Change	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.	Baseline and 12 weeks	No
Secondary	N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)	Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.	Baseline and Week 12	No
Secondary	World Health Organization (WHO) Functional Class	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.	Baseline and 12 Weeks	No
Secondary	Drug Administration Activities Questionnaire	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).	Baseline and 12 weeks	No