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 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD®
Overview
- Phase
- Phase 3
- Intervention
- Iloprost PD-6
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Actelion
- Enrollment
- 63
- Locations
- 36
- Primary Endpoint
- Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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®)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent prior to initiation of any study-mandated procedure.
- •Male or female patients aged 18-85 years.
- •Patients with symptomatic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class III or IV at the time of initiation of iloprost inhalation (Ventavis®) therapy using the Power Disc-6 (PD-6).
- •Patients with the following types of pulmonary arterial hypertension (PAH) belonging to World Health Organization (WHO) Group I:
- •1.1: Idiopathic (IPAH)
- •1.2: Familial (FPAH)
- •1.3: Associated with (APAH)
- •1.3.1: Collagen vascular disease
- •1.3.2: Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
- •1.3.4: Human immunodeficiency virus (HIV) infection
Exclusion Criteria
- •PAH belonging to WHO group II-V.
- •PAH belonging to WHO group I other than that listed in the inclusion criteria, i.e., PAH associated with:
- •1.3.3: Portal hypertension
- •1.3.6: Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
- •1.4: Associated with significant venous or capillary involvement:
- •1.4.1: Pulmonary veno-occlusive disease (PVOD)
- •1.4.2: Pulmonary capillary hemangiomatosis (PCH).
- •Receipt of any prostacyclin or prostacyclin analog other than iloprost within 12 weeks before screening.
- •Anticipation of the need for intravenous prostacyclin use within 28 days of starting the Power Disc-15 (PD-15).
- •HIV-seropositive with any of the following:
Arms & Interventions
Iloprost
The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6. The single-arm design allowed each patient to serve as his/her own control
Intervention: Iloprost PD-6
Iloprost
The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6. The single-arm design allowed each patient to serve as his/her own control
Intervention: Iloprost PD-15
Outcomes
Primary Outcomes
Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
Time Frame: From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of patients reporting at least one treatment-emergent AE/Serious AE
Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE
Time Frame: From the first dose of investigational product to study discontinuation, an average of approximately 268 days
Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment
Number of Patients Reporting Treatment-emergent Serious AEs
Time Frame: From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours
Number of patients reporting at least one treatment-emergent serious AEs
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Time Frame: Day 1
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Time Frame: Day 28
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Time Frame: an average of approximately 268 days
Systolic blood pressure was measured at the end of study visit
Change in Systolic Blood Pressure - (Period 1 to Period 2)
Time Frame: Day 1 and Day 28
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)
Change in Systolic Blood Pressure - (Period 1 to Period 3)
Time Frame: Day 1 and End of study visit, an average of approximately 268 days
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)
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Time Frame: Day 1
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Time Frame: Day 28
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Time Frame: an average of approximately 268 days
Diastolic blood pressure was measured at the end of study visit
Change in Diastolic Blood Pressure - (Period 1 to Period 2)
Time Frame: Day 1 and Day 28
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)
Change in Diastolic Blood Pressure - (Period 1 to Period 3)
Time Frame: Day 1 and End of study visit, an average of approximately 268 days
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)
Heart Rate - Iloprost PD-6 (Period 1)
Time Frame: Day 1
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 2)
Time Frame: Day 28
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 3)
Time Frame: an average of approximately 268 days
Heart rate was measured at the end of study visit
Change in Heart Rate - (Period 1 to Period 2)
Time Frame: Day 1 and Day 28
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)
Change in Heart Rate - (Period 1 to Period 3)
Time Frame: Day 1 and End of study visit, an average of approximately 268 days
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)
Secondary Outcomes
- Average Inhalation Time - Iloprost PD-6 (Period 1)(average of approximately 28 days)
- Average Inhalation Time - Iloprost PD-15 (Period 2)(average of approximately 28 days)
- Average Inhalation Time - Iloprost PD-15 (Period 3)(average of approximately 240 days)
- Change in Average Inhalation Time - (Period 1 to Period 2)(average approximately 56 days)
- Average Number of Days of Dosing - Iloprost PD-6 (Period 1)(average of approximately 28 days)
- Average Number of Days of Dosing - Iloprost PD-15 (Period 2)(average of approximately 28 days)
- Average Number of Days of Dosing - Iloprost PD-15 (Period 3)(average of approximately 240 days)
- Change in Average Number of Days of Dosing - (Period 1 to Period 2)(average approximately 56 days)
- Average Number of Daily Doses - Iloprost PD-6 (Period 1)(average of approximately 28 days)
- Average Number of Daily Doses - Iloprost PD-15 (Period 2)(average of approximately 28 days)
- Average Number of Daily Doses - Iloprost PD-15 (Period 3)(average of approximately 240 days)
- Change in Average Number of Daily Doses - (Period 1 to Period 2)(average approximately 56 days)
- Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)(average of approximately 28 days)
- Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)(average of approximately 28 days)
- Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)(average of approximately 240 days)
- Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)(average approximately 56 days)
- New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)(average of approximately 28 days)
- NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)(average of approximately 28 days)
- NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))(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)(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)(average approximately 268 days)
- Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)(average of approximately 28 days)
- Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)(average of approximately 28 days)
- Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))(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(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(average of approximately 268 days)