Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01268553
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2010-12-29
Brief Title:
Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Overview
Official Title:
Transition From Parenteral Prostanoids to Inhaled Treprostinil
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess tolerability and clinical effects of transition from intravenous IV needle in the vein or subcutaneous SQ needle in the skin to the recently-approved inhaled treprostinil Tyvaso for the treatment of pulmonary arterial hypertension PAH
Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients
The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for treatment of PAH many years ago While these medications improve exercise capacity and the symptoms of PAH they are given by injection and thus have several side effects such as pain and catheter infection This has resulted in many patients either refusing to take the medication or quitting these medications because of not tolerating them
The only other form of prostacyclin treatment available for PAH patients is inhaled There are 2 inhaled prostacyclins approved for PAH however one of these requires at least 6 inhalations per day every day and takes about 30 minutes to inhale each time Thus it has not been a regularly-used medication and issues surrounding compliance make it a riskier drug to use if patients do not get their full doses every day The other inhaled medication treprostinil was approved a few months ago only needs to be given 4 times a day and takes about 2-3 minutes to inhale
Since inhaled treprostinil can be administered easily it is anticipated that many patients will transition from epoprostenol or treprostinil to the recently approved inhaled treprostinil however we do not know if this is a safe or effective way to manage patients Thus the goal of this prospective study is to gather observational data regarding how that switch is made tolerability of the switch and to the extent possible with this methodology assess clinical effects of the switch
This is a prospective study Twenty patients 18 years old with PAH will be enrolled Patients enrolled will be those in whom a clinical decision to convert from either IV epoprostenol IV treprostinil or SQ treprostinil to inhaled treprostinil therapy has been made This is usually the result of patients asking to switch to inhaled therapy but only allowed by physicians if they feel the switch would be safe
If eligible and after informed consent patients will have a history and physical examination a 6 min walk test a cardiopulmonary exercise test CPET blood tests and a symptom questionnaire will be filled out Patients will then be admitted to the hospital where a monitoring catheter will be placed inside the patients heart and inhaled treprostinil will be initiated while the dose of IVSQ medication is reduced over about 24-26 hours
Clinical follow-up will be at weeks 1 4 and 12
The procedures above are all part of the routine clinical care that patients would receive if they were to be transitioned to inhaled therapy including the hospitalization and catheterization The criteria for them to be able to be switched are conservative Pressure in their heart and lungs must be low mPAP 40 mmHg and RAP 12 mmHg on catheterization and their dose of IV or SQ medication must be low 20 ngkgmin Regarding the patient subset enrolled in this study in whom a clinical decision to convert transition therapy has been made we will try to ensure that our clinical decision-making will not be influenced by the need to enroll subjects in the study by explicitly noting the potential for conflict of interest with each patient addressed in the ICF We will not make a clinical decision for our patients based on the desire to fill the study numbers and every will be made to avoid the potential for a perceived conflict of interest
Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients
The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for treatment of PAH many years ago While these medications improve exercise capacity and the symptoms of PAH they are given by injection and thus have several side effects such as pain and catheter infection This has resulted in many patients either refusing to take the medication or quitting these medications because of not tolerating them
The only other form of prostacyclin treatment available for PAH patients is inhaled There are 2 inhaled prostacyclins approved for PAH however one of these requires at least 6 inhalations per day every day and takes about 30 minutes to inhale each time Thus it has not been a regularly-used medication and issues surrounding compliance make it a riskier drug to use if patients do not get their full doses every day The other inhaled medication treprostinil was approved a few months ago only needs to be given 4 times a day and takes about 2-3 minutes to inhale
Since inhaled treprostinil can be administered easily it is anticipated that many patients will transition from epoprostenol or treprostinil to the recently approved inhaled treprostinil however we do not know if this is a safe or effective way to manage patients Thus the goal of this prospective study is to gather observational data regarding how that switch is made tolerability of the switch and to the extent possible with this methodology assess clinical effects of the switch
This is a prospective study Twenty patients 18 years old with PAH will be enrolled Patients enrolled will be those in whom a clinical decision to convert from either IV epoprostenol IV treprostinil or SQ treprostinil to inhaled treprostinil therapy has been made This is usually the result of patients asking to switch to inhaled therapy but only allowed by physicians if they feel the switch would be safe
If eligible and after informed consent patients will have a history and physical examination a 6 min walk test a cardiopulmonary exercise test CPET blood tests and a symptom questionnaire will be filled out Patients will then be admitted to the hospital where a monitoring catheter will be placed inside the patients heart and inhaled treprostinil will be initiated while the dose of IVSQ medication is reduced over about 24-26 hours
Clinical follow-up will be at weeks 1 4 and 12
The procedures above are all part of the routine clinical care that patients would receive if they were to be transitioned to inhaled therapy including the hospitalization and catheterization The criteria for them to be able to be switched are conservative Pressure in their heart and lungs must be low mPAP 40 mmHg and RAP 12 mmHg on catheterization and their dose of IV or SQ medication must be low 20 ngkgmin Regarding the patient subset enrolled in this study in whom a clinical decision to convert transition therapy has been made we will try to ensure that our clinical decision-making will not be influenced by the need to enroll subjects in the study by explicitly noting the potential for conflict of interest with each patient addressed in the ICF We will not make a clinical decision for our patients based on the desire to fill the study numbers and every will be made to avoid the potential for a perceived conflict of interest
Detailed Description:
Purpose This study proposes to investigate the safety tolerability and feasibility of transitioning patients with PAH from intravenous or subcutaneous prostacyclin analogs to inhaled treprostinil using a defined protocol Twenty-one patients from three PH specialty referral centers will be enrolled in this 12-week prospective open-label study If subjects meet inclusion and exclusion criteria they will be switched from intravenous or subcutaneous prostacyclin analogs to inhaled treprostinil according to a defined transition protocol
Background Parenteral prostacyclin analogs improve exercise capacity and survival in patients with pulmonary arterial hypertension PAH however practical issues can limit their tolerability in some patients The prostacyclin analogue treprostinil has been shown to improve exercise capacity and signssymptoms of PAH while delivered via four 2-3 minute inhalation periods per day In addition there is extensive worldwide experience with the subcutaneous and intravenous forms of treprostinil with documented safety efficacy and tolerability
Prior published studies have examined the feasibility of prostacyclin transitions including transition from intravenous epoprostenol to non-parenteral PAH treatments from subcutaneous to intravenous treprostinil and from intravenous prostanoids to subcutaneous treprostinil
There is currently no published experience examining the safety tolerability and feasibility of transitioning patients from parenteral prostanoids to inhaled treprostinil
Background Parenteral prostacyclin analogs improve exercise capacity and survival in patients with pulmonary arterial hypertension PAH however practical issues can limit their tolerability in some patients The prostacyclin analogue treprostinil has been shown to improve exercise capacity and signssymptoms of PAH while delivered via four 2-3 minute inhalation periods per day In addition there is extensive worldwide experience with the subcutaneous and intravenous forms of treprostinil with documented safety efficacy and tolerability
Prior published studies have examined the feasibility of prostacyclin transitions including transition from intravenous epoprostenol to non-parenteral PAH treatments from subcutaneous to intravenous treprostinil and from intravenous prostanoids to subcutaneous treprostinil
There is currently no published experience examining the safety tolerability and feasibility of transitioning patients from parenteral prostanoids to inhaled treprostinil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None