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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:
United Therapeutics
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
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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 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. |
Resource links provided by NLM:
Further study details as provided by United Therapeutics:
Primary Outcome Measures:
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
| 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 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741819
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 | |
| 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
| 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 |
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 |
ClinicalTrials.gov processed this record on August 18, 2017