Back to resultsRapid Switch From Flolan to Remodulin in the Outpatient Clinic
Primary Purpose
Hypertension, Pulmonary
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
treprostinil sodium
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Pulmonary arterial hypertension, treatment satisfaction, rapid switch, remodulin, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Be between 18 years and 70 years of age
- Be male or if female, be physiologically incapable of childbearing or practicing an acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).
- Have a current World Health Organization (WHO) functional classification of II-III status
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
- In the opinion of the investigator, be hemodynamically stable with no signs or symptoms of disease progression
- Be receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month prior to Baseline.
- Have a central intravenous catheter in place.
- Have a baseline six-minute walk distance of at least 150 meters.
- Be optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month prior to baseline assessments.
- Be mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion Criteria:
- Be a nursing or pregnant woman
- Have had 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.
- Have any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Have an on-going central venous line infection within the past 30 days.
- Have evidence of predominant left-sided heart disease
- Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
- Have 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.
- Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Have the presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treprostinil sodium
Arm Description
all subjects had switched from IV epoprostenol to IV treprostinil sodium
Outcomes
Primary Outcome Measures
Change in Six Minute Walk Distance
Secondary Outcome Measures
Change in WHO Functional Classification
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
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)
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
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
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
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
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
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643604
Brief Title
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to availability of eligible subjects at center and enrollment competition with other studies.
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
Pulmonary arterial hypertension, treatment satisfaction, rapid switch, remodulin, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treprostinil sodium
Arm Type
Experimental
Arm Description
all subjects had switched from IV epoprostenol to IV treprostinil sodium
Intervention Type
Drug
Intervention Name(s)
treprostinil sodium
Other Intervention Name(s)
Remodulin, Flolan
Intervention Description
rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium
Primary Outcome Measure Information:
Title
Change in Six Minute Walk Distance
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change in WHO Functional Classification
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Borg Dyspnea Score Immediately After Six Minute Walk
Description
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).
Time Frame
Baseline and Week 8
Title
Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Score on Treatment Satisfaction Questionnaire for Medication
Description
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.
Time Frame
Baseline and Week 8
Title
Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol
Description
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
Time Frame
Baseline and Week 8
Title
Change in PAH Signs and Symptoms- Fatigue
Description
The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change From in Signs and Symptoms of PAH- Edema
Description
The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change in Signs and Symptoms of PAH- Dyspnea
Description
The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change in Signs and Symptoms of PAH- Orthopnea
Description
The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change in Signs and Symptoms of PAH- Dizziness
Description
The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change in Signs and Symptoms of PAH- Syncope
Description
The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Change in Signs and Symptoms of PAH- Chest Pain
Description
The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe.
Time Frame
Baseline and Week 8
Title
Patient Impression of Change Questionnaire
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be between 18 years and 70 years of age
Be male or if female, be physiologically incapable of childbearing or practicing an acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).
Have a current World Health Organization (WHO) functional classification of II-III status
Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
In the opinion of the investigator, be hemodynamically stable with no signs or symptoms of disease progression
Be receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month prior to Baseline.
Have a central intravenous catheter in place.
Have a baseline six-minute walk distance of at least 150 meters.
Be optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month prior to baseline assessments.
Be mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion Criteria:
Be a nursing or pregnant woman
Have had 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.
Have any PAH medication discontinued within the week prior to study entry.
Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Have an on-going central venous line infection within the past 30 days.
Have evidence of predominant left-sided heart disease
Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
Have 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.
Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
Have the presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Tapson, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
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Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
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