- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439946
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California San Francisco (UCSF) Medical Center
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New York
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New York, New York, United States, 10065
- THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73122
- Integris Baptist Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 65 years
Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
Group 1 pulmonary arterial hypertension
- Idiopathic pulmonary arterial hypertension (IPAH)
- Familial pulmonary arterial hypertension (FPAH)
Associated pulmonary arterial hypertension (APAH):
- collagen vascular disease
- congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry.
- portal hypertension
- drugs and toxins
- 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):
- Total Lung Capacity ≤ 60% (predicted) or
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treprostinil
IV treprostinil continuous infusion via Crono Five infusion pump.
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rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump
Other Names:
Used for administration of IV Remodulin (treprostinil)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)
Time Frame: Week 8
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The administration of the 6MWD test and specifications of the testing area were consistent with the American Thoracic Society guidelines and the usual practice of the investigative site [American Thoracic Society (ATS) guidelines; 2002].
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Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline at Week 8 in Borg Dyspnea Score Immediately After Six Minute Walk Test
Time Frame: Week 8
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The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-Minute Walk Test.
Scores range from 0 (for the best condition) to 10 (for the worst condition).
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Week 8
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Change From Baseline at Week 8 in World Health Organization (WHO) Functional Classification
Time Frame: Week 8
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WHO functional class is a system to help clinicians determine how limited a patient is in their ability to do the activities of daily living.
The scale ranges from class I to class IV.
In general, patients with more severe Pulmonary Hypertension (PH) tend to have a higher functional class.
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Week 8
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Change From Baseline at Week 8 in Symptoms of PAH- Fatigue
Time Frame: Week 8
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The presence or absence of fatigue was documented.
If present, the intensity of fatigue was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in Symptoms of PAH- Dyspnea
Time Frame: Week 8
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The presence or absence of dyspnea was documented.
If present, the intensity of dyspnea was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in Symptoms of PAH- Edema
Time Frame: Week 8
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The presence or absence of edema was documented.
If present, the intensity of edema was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in PAH Symptoms- Orthopnea
Time Frame: Week 8
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The presence or absence of orthopnea was documented.
If present, the intensity of orthopnea was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in PAH Symptoms- Dizziness
Time Frame: Week 8
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The presence or absence of dizziness was documented.
If present, the intensity of dizziness was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in PAH Symptoms- Syncope
Time Frame: Week 8
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The presence or absence of syncope was documented.
If present, the intensity of syncope was rated mild, moderate, or severe.
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Week 8
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Change From Baseline at Week 8 in PAH Symptoms- Chest Pain
Time Frame: Week 8
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The presence or absence of chest pain was documented.
If present, the intensity of chest pain was rated mild, moderate, or severe.
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Week 8
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Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Time Frame: Week 8
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A Drug Administration Activities Diary, used by subjects to record in detail the amount of time (in minutes) spent on specifically-defined drug preparation/administration activities (e.g.
diluting drug, preparing reservoir, and changing tubing), was completed over a 7-day period during the Screening period while on epoprostenol and repeated at Week 7 following transition to Remodulin.
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Week 8
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Subject Responses to the Patient Impression of Change Questionnaire (Administered at Week 8 Only)
Time Frame: Week 8
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A Patient Global Impression of Change Questionnaire, which consists of three items that ask the subject to rate changes (much better, somewhat better, about the same, somewhat worse, much worse) in their symptoms of PAH, the amount of time spent on activities associated with preparing and administering PAH therapy, and their satisfaction with their PAH therapy since transitioning from epoprostenol to intravenous Remodulin was conducted at Week 8 only and responses are reported as frequency distributions.
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Week 8
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Change From Baseline at Week 8 in Score on Quality of Life (QOL) Questionnaire - The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Time Frame: Baseline and Week 8
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The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning and QOL.
The CAMPHOR was completed at Baseline and at Week 8.
The CAMPHOR consists of 3 scales: 1.
A 25-item overall symptoms scale scored 0-25, with a higher score indicating the presence of more symptoms.
2. A 15 item Activity/Functioning scale scored 0-30, where a low score indicates good functioning.
3. A 25-item QoL scale scored 0-25, with a high score indicating poor QoL.
Additionally, a total score was recorded by adding up the the scores from the 3 above scales.
The Symptom and QoL scales have dichotomous ('True'/'Not true') response options while the Activity/Functioning scale has three-point ('Able to do on own without difficulty'/'Able to do on own with difficulty'/'Unable to do on own') response options.
The CAMPHOR score range can be from 0 to 80.
A reduction in score denotes improved heath status.
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Baseline and Week 8
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Change From Baseline at Week 8 in Score on Treatment Satisfaction Questionnaire- The Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Baseline and Week 8
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The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-question questionnaire that measures the level of satisfaction or dissatisfaction patients have with their study medication in 4 areas: effectiveness (3 questions), side effects (5 questions), convenience (3 questions), and global satisfaction (3 questions).
With the exception of the first side effects question (a yes or no question), all items have 5 or 7 responses which are scored from 1 (least satisfied) to 5 or 7 (most satisfied).
A total score is then summed for each domain on the following scales: effectiveness 1-21, side effects 1-20, convenience 1-21, and global satisfaction 1-17.
The TSQM score range can be from 0 to 100.
Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.
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Baseline and Week 8
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Remzi Bag, MD, Integris Baptist Medical Center
- Principal Investigator: Evelyn Horn, MD, Weill Medical College of Cornell University
- Principal Investigator: Teresa DeMarco, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIV-PH-410
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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