A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive. Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day
Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
Number of patients reporting at least one treatment-emergent AE/Serious AE
Time frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE
Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
Time frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days
Number of Patients Reporting Treatment-emergent Serious AEs
Number of patients reporting at least one treatment-emergent serious AEs
Time frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Time frame: Day 1
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Time frame: Day 28
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Systolic blood pressure was measured at the end of study visit
Time frame: an average of approximately 268 days
Change in Systolic Blood Pressure - (Period 1 to Period 2)
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
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University of South Alabama Medical
Mobile, Alabama, United States
Arizona Pulmonary Associates, Ltd.
Phoenix, Arizona, United States
Kaiser Foundation Hospital
Los Angeles, California, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
University of Florida
Gainesville, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Suncoast Lung Research, LLC
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
...and 26 more locations
Time frame: Day 1 and Day 28
Change in Systolic Blood Pressure - (Period 1 to Period 3)
Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Time frame: Day 1
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Time frame: Day 28
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Diastolic blood pressure was measured at the end of study visit
Time frame: an average of approximately 268 days
Change in Diastolic Blood Pressure - (Period 1 to Period 2)
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Time frame: Day 1 and Day 28
Change in Diastolic Blood Pressure - (Period 1 to Period 3)
Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Heart Rate - Iloprost PD-6 (Period 1)
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Time frame: Day 1
Heart Rate - Iloprost PD-15 (Period 2)
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Time frame: Day 28
Heart Rate - Iloprost PD-15 (Period 3)
Heart rate was measured at the end of study visit
Time frame: an average of approximately 268 days
Change in Heart Rate - (Period 1 to Period 2)
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)
Time frame: Day 1 and Day 28
Change in Heart Rate - (Period 1 to Period 3)
Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)
Time frame: Day 1 and End of study visit, an average of approximately 268 days
Average Inhalation Time - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Inhalation Time - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 240 days
Change in Average Inhalation Time - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average approximately 56 days
Average Number of Days of Dosing - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Number of Days of Dosing - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 240 days
Change in Average Number of Days of Dosing - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average approximately 56 days
Average Number of Daily Doses - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Average Number of Daily Doses - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 240 days
Change in Average Number of Daily Doses - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average approximately 56 days
Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 28 days
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average of approximately 240 days
Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)
The time and date of inhalation, inhalation time (minutes), and dose completion status (\<12.5%, ≥12.5 to \<100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.
Time frame: average approximately 56 days
New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Time frame: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Time frame: average of approximately 28 days
NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Time frame: average of approximately 268 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Time frame: average approximately 28 days
Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)
Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.
Time frame: average approximately 268 days
Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse. On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit.
Time frame: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse. On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Time frame: average of approximately 28 days
Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse. On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Time frame: average of approximately 268 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse. On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Time frame: average of approximately 28 days
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit
The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse. On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit.
Time frame: average of approximately 268 days