Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
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|ClinicalTrials.gov Identifier: NCT00643604|
Recruitment Status : Terminated (Due to availability of eligible subjects at center and enrollment competition with other studies.)
First Posted : March 26, 2008
Results First Posted : June 21, 2013
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary||Drug: treprostinil sodium||Phase 4|
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 IV and 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. Furthermore, 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 using the CADD legacy pump.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||February 2012|
Experimental: treprostinil sodium
all subjects had switched from IV epoprostenol to IV treprostinil sodium
Drug: treprostinil sodium
rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
- Change in Six Minute Walk Distance [ Time Frame: Baseline and Week 8 ]
- Change in WHO Functional Classification [ Time Frame: Baseline and Week 8 ]Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.
- Change in Borg Dyspnea Score Immediately After Six Minute Walk [ Time Frame: Baseline and Week 8 ]The Borg Dyspnea Score is a 10-point scale rating the maximum level of dyspnea experienced after the Six-Minute Walk Test. Scores range from 0 (for the best condition) to 10 (for the worst condition).
- Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) [ Time Frame: Baseline and Week 8 ]The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR), a validated PAH-specific instrument consisting of 65 items used to assess symptoms, functioning 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.
- Change in Score on Treatment Satisfaction Questionnaire for Medication [ Time Frame: Baseline and Week 8 ]The Treatment Satisfaction Questionnaire for Medication (TSQM), a validated generic measure of treatment satisfaction consisting of 14 Likert-response items comprising four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. The TSQM was completed at baseline and at Week 8. The TSQM consists of 13 items that made up three specific scales (Effectiveness, Side effects, Convenience) and one global satisfaction scale. TSQM items are scaled using either a 5-point or 7-point scale. Five-point scales are used for unidimensional continua (e.g. extremely satisfied to not at all), while 7-point scales are used for bipolar continua(e.g., extremely positive to extremely negative. Non-neutral midpoints are used for 7-point scales, resulting in a greater range of positive response options than negative options for these items. Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.
- Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol [ Time Frame: Baseline and Week 8 ]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. Drug Administration Activities Diary results are reported as average time per week spent on drug administration activities
- Change in PAH Signs and Symptoms- Fatigue [ Time Frame: Baseline and Week 8 ]The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
- Change From in Signs and Symptoms of PAH- Edema [ Time Frame: Baseline and Week 8 ]The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
- Change in Signs and Symptoms of PAH- Dyspnea [ Time Frame: Baseline and Week 8 ]The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
- Change in Signs and Symptoms of PAH- Orthopnea [ Time Frame: Baseline and Week 8 ]The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
- Change in Signs and Symptoms of PAH- Dizziness [ Time Frame: Baseline and Week 8 ]The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
- Change in Signs and Symptoms of PAH- Syncope [ Time Frame: Baseline and Week 8 ]The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
- Change in Signs and Symptoms of PAH- Chest Pain [ Time Frame: Baseline and Week 8 ]The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
- Patient Impression of Change Questionnaire [ Time Frame: Week 8 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643604
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Victor Tapson, MD||Duke Health|