Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: treprostinil (Drug); Crono Five ambulatory pump (Device)
Phase: Phase 4
Status: Terminated
Sponsored by: United Therapeutics Official(s) and/or principal investigator(s): Remzi Bag, MD, Principal Investigator, Affiliation: INTEGRIS Baptist Medical Center Evelyn Horn, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University Teresa DeMarco, MD, Principal Investigator, Affiliation: University of California, San Francisco
Summary
The purpose of this 8-week study is to compare the effects of switching from intravenous
Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved
therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need
to be mixed daily and is stable at room temperature, so there is no need for ice packs. In
addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every
8 hours (without ice packs) with Flolan. Flolan is given using a type of portable
medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given
using a smaller and lighter medication pump called the Crono Five infusion pump. This study
will also assess the effect that changing to Remodulin will have on treatment satisfaction
and patient quality of life.
Clinical Details
Official title: Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
Secondary outcome: Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk TestChange From Baseline at Week 8 in World Health Organization (WHO) Functional Classification Change From Baseline at Week 8 in Symptoms of PAH- Fatigue Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea Change From Baseline at Week 8 in Symptoms of PAH- Edema Change From Baseline at Week 8 in PAH Symptoms- Orthopnea Change From Baseline at Week 8 in PAH Symptoms- Dizziness Change From Baseline at Week 8 in PAH Symptoms- Syncope Change From Baseline at Week 8 in PAH Symptoms- Chest Pain Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM) Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Detailed description:
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary
arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality
common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure
causes an increase in right ventricular afterload, impairing right ventricular function and
ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen
survival time, to ameliorate symptoms of PAH, and to improve health related quality of life
(HRQOL).
Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent
pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in
vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon
bioequivalence of the intravenous (IV) and subcutaneous (SC) routes of administration.
Remodulin is more chemically stable than epoprostenol and may offer potential safety and
convenience advantages compared to intravenous epoprostenol that may impact Health Related
Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not
need to be mixed daily and is stable at room temperature eliminating the need for ice packs.
Since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5
minutes) there is less risk of cardiovascular collapse from a sudden interruption of
infusion, such as a line clog. In an open-label study in Europe, patients who were using a
type of portable medication pump called the CADD Legacy pump were rapidly switched from
Flolan to Remodulin with no serious side effects. This study will examine effects of
switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in
HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to
Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller
pump called the Crono Five.
Participation in this study will last approximately 10 weeks. Study procedures include
routine blood tests, medical history, physical exams, disease evaluation, exercise tests and
patient questionnaires. Participants will have 4 visits during the study and will spend at
least 1 night in the hospital.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 to 65 years
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
1. Group 1 pulmonary arterial hypertension
- Idiopathic pulmonary arterial hypertension (IPAH)
- Familial pulmonary arterial hypertension (FPAH)
- Associated pulmonary arterial hypertension (APAH):
1. collagen vascular disease
2. congenital systemic-to-pulmonary shunt repaired greater than 5 years
prior to study entry.
3. portal hypertension
4. drugs and toxins
2. Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary
hypertension (CTEPH)
- WHO Class II-III
- Currently receiving intravenous epoprostenol therapy for at least three months and a
stable dose for at least one month.
- Have central intravenous catheter
- Optimally treated with conventional pulmonary hypertension therapy and clinically
stable for at least one month.
- Mentally and physically capable of learning to administer Remodulin using an
intravenous infusion pump.
Exclusion Criteria:
- nursing or pregnant woman
- received a new type of chronic therapy (including but not limited to oxygen, a
different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for
pulmonary hypertension added within the last month.
- Had any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3
months.
- Had a central venous line infection within the past 30 days.
- Previous documented evidence of significant parenchymal lung disease as evidenced by
pulmonary function tests as follows (any one of the following):
1. Total Lung Capacity ≤ 60% (predicted) or
2. If Total Lung Capacity is between 60% and 70% (predicted), a High Resolution
Computed Tomography (CT) scan must be performed to rule out diffuse interstitial
fibrosis or alveolitis
- History of or evidence of left-sided heart disease
- Having any other disease that is associated with pulmonary hypertension (e. g. sickle
cell anemia, schistosomiasis).
- Having a musculoskeletal disorder (e. g. arthritis, artificial leg, etc.) or any other
disease, which is thought to limit ambulation, or be connected to a machine, which is
not portable.
- Uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater
than 160 millimeters of mercury (mmHg) or diastolic blood pressure greater than 100
mmHg.
- Chronic renal insufficiency as defined by serum creatinine greater than 2. 5
milligrams per deciliter (mg/dL) or the requirement for dialysis.
- Receiving an investigational drug, have in place an investigational device, or have
participated in an investigational drug study within the past 30 days.
- Active infection, or any other ongoing condition that would interfere with the
interpretation of study assessments.
- The presence of any physiological or psychological condition that contraindicates the
administration of Remodulin.
Locations and Contacts
University of California San Francisco (UCSF) Medical Center, San Francisco, California 94143, United States
THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center, New York, New York 10065, United States
Integris Baptist Medical Center, Oklahoma City, Oklahoma 73122, United States
Additional Information
Starting date: February 2007
Last updated: June 12, 2013
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