search
Back to results

Iloprost Power Disc-15 in Pulmonary Arterial Hypertension (INHALE-15)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Iloprost PD-6
Iloprost PD-15
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring pulmonary arterial hypertension, inhaled therapy, power disc-15

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
      • 1.3.5: Drugs and toxins

  • PAH confirmed by the most recent right heart catheterization showing:

    • Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest
    • Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.
    • Pulmonary vascular resistance (PVR) > 240 dyn-sec/cm^5
  • Compliant with a treatment regimen of commercial iloprost inhalation (Ventavis® 5 μg) using the I-neb® AAD® equipped with the PD-6 for at least 4 weeks prior to screening.
  • Pulmonary function tests (PFTs) including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and total lung capacity (TLC), performed within 6 months of screening.
  • If taking other medications for PAH, these must have been stable for 60 days prior to baseline.
  • If taking corticosteroids, these must have been stable for 60 days prior to baseline.

  • Women of childbearing potential with a negative urine pre-treatment pregnancy test at baseline and who:

    • consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of < 1%,
    • are sexually abstinent, or
    • have a vasectomized partner.

A woman is considered to have childbearing potential unless she meets at least one of the following criteria:

  • Previous bilateral salpingo-oophorectomy or hysterectomy
  • Premature ovarian failure confirmed by a specialist gynecologist
  • XY genotype, Turner syndrome, uterine agenesis
  • Is aged > 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months

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:

    • Concomitant active opportunistic infections within 6 months prior to screening
    • Detectable viral load within 6 months of screening
    • CD4+ T-cell count < 200 mm^3 within 3 months of screening
    • Changes in antiretroviral regimen within 3 months of screening
    • Anticipated changes in antiretroviral regimen during study periods 1 or 2
    • Using inhaled pentamidine
  • Systemic hypotension with systolic blood pressure < 95 mmHg.
  • Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement).

  • History of left-sided heart disease, including any of the following:

    • hemodynamically significant aortic or mitral valve disease
    • restrictive or congestive cardiomyopathy
    • left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
    • coronary artery disease with continuing symptoms of angina pectoris
    • life-threatening cardiac arrhythmias
  • Atrial septostomy within 1 year.
  • History of pulmonary embolism prior to diagnosis of PAH unless it can be documented that chronic thromboembolic pulmonary hypertension (CTEPH) has been specifically excluded (e.g., ventilation/perfusion (VQ) scan, pulmonary angiogram).
  • Restrictive lung disease: TLC < 60% of normal predicted value.
  • Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 or clinically relevant chronic obstructive lung disease or asthma (including any patient requiring concomitant medication to control symptoms of bronchospasm including as needed (p.r.n.) use).
  • Clinically relevant bleeding disorder or active bleeding.
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C or hepatic cirrhosis.
  • Pregnant or breast-feeding.
  • Chronic renal insufficiency, as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis.
  • Hemoglobin < 75% of the lower limit of normal range.
  • Any condition that prevents compliance with the protocol or adherence to therapy or ability to provide informed consent.
  • Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment.

Sites / Locations

  • University of South Alabama Medical
  • Arizona Pulmonary Associates, Ltd.
  • Kaiser Foundation Hospital
  • West Los Angeles VA Healthcare Center
  • Santa Barbara Cottage Hospital
  • University of Florida
  • Central Florida Pulmonary Group
  • Suncoast Lung Research, LLC
  • Northwestern University
  • Kentuckiana Pulmonary Associates
  • LSU Health Sciences Center
  • University of Maryland Medical Center
  • Johns Hopkins University
  • Children's Hospital Boston
  • Henry Ford Health System
  • Mayo Clinic
  • Saint Louis University
  • Winthrop University Hospital
  • North Shore Long Island Jewish Health System
  • Beth Israel Medical Center
  • Weill Cornell Medical Center
  • SUNY Upstate Medical University
  • The Lindner Clinical Trial Center
  • University of Cincinnati
  • The Ohio State University Medical Center
  • The Ohio State University, The Dorothy M. Davis Heart & Lung Research Institute
  • INTEGRIS Baptist Medical Center, Inc.
  • Temple University Hospital
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center-Presbyterian
  • Medical University of South Carolina
  • University of Texas Southwestern Medical Center at Dallas
  • Intermountain Medical Center
  • Central Utah Clinic, P.C.
  • Virginia Commonwealth University Health System
  • Comprehensive Cardiovascular Care Group LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Iloprost

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
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
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
Number of patients reporting at least one treatment-emergent serious AEs
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Systolic blood pressure was measured at the end of study visit
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)
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)
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Diastolic blood pressure was measured at the end of study visit
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)
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)
Heart Rate - Iloprost PD-6 (Period 1)
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 2)
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Heart Rate - Iloprost PD-15 (Period 3)
Heart rate was measured at the end of study visit
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)
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)

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 24, 2008
Last Updated
March 27, 2013
Sponsor
Actelion
search

1. Study Identification

Unique Protocol Identification Number
NCT00723554
Brief Title
Iloprost Power Disc-15 in Pulmonary Arterial Hypertension
Acronym
INHALE-15
Official Title
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®
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
sponsor's decision
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
pulmonary arterial hypertension, inhaled therapy, power disc-15

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iloprost
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Iloprost PD-6
Other Intervention Name(s)
Ventavis
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Iloprost PD-15
Other Intervention Name(s)
Ventavis
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Patients Reporting Treatment-emergent Adverse Events (AEs)
Description
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
Title
Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE
Description
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
Title
Number of Patients Reporting Treatment-emergent Serious AEs
Description
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
Title
Systolic Blood Pressure - Iloprost PD-6 (Period 1)
Description
Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Time Frame
Day 1
Title
Systolic Blood Pressure - Iloprost PD-15 (Period 2)
Description
Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Time Frame
Day 28
Title
Systolic Blood Pressure - Iloprost PD-15 (Period 3)
Description
Systolic blood pressure was measured at the end of study visit
Time Frame
an average of approximately 268 days
Title
Change in Systolic Blood Pressure - (Period 1 to Period 2)
Description
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)
Time Frame
Day 1 and Day 28
Title
Change in Systolic Blood Pressure - (Period 1 to Period 3)
Description
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
Title
Diastolic Blood Pressure - Iloprost PD-6 (Period 1)
Description
Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15
Time Frame
Day 1
Title
Diastolic Blood Pressure - Iloprost PD-15 (Period 2)
Description
Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15
Time Frame
Day 28
Title
Diastolic Blood Pressure - Iloprost PD-15 (Period 3)
Description
Diastolic blood pressure was measured at the end of study visit
Time Frame
an average of approximately 268 days
Title
Change in Diastolic Blood Pressure - (Period 1 to Period 2)
Description
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
Title
Change in Diastolic Blood Pressure - (Period 1 to Period 3)
Description
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
Title
Heart Rate - Iloprost PD-6 (Period 1)
Description
Heart rate was measured immediately prior to first dosing with Iloprost PD-15
Time Frame
Day 1
Title
Heart Rate - Iloprost PD-15 (Period 2)
Description
Heart rate was measured on Day 28 of treatment with Iloprost PD-15
Time Frame
Day 28
Title
Heart Rate - Iloprost PD-15 (Period 3)
Description
Heart rate was measured at the end of study visit
Time Frame
an average of approximately 268 days
Title
Change in Heart Rate - (Period 1 to Period 2)
Description
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
Title
Change in Heart Rate - (Period 1 to Period 3)
Description
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
Secondary Outcome Measure Information:
Title
Average Inhalation Time - Iloprost PD-6 (Period 1)
Description
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
Title
Average Inhalation Time - Iloprost PD-15 (Period 2)
Description
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
Title
Average Inhalation Time - Iloprost PD-15 (Period 3)
Description
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
Title
Change in Average Inhalation Time - (Period 1 to Period 2)
Description
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
Title
Average Number of Days of Dosing - Iloprost PD-6 (Period 1)
Description
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
Title
Average Number of Days of Dosing - Iloprost PD-15 (Period 2)
Description
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
Title
Average Number of Days of Dosing - Iloprost PD-15 (Period 3)
Description
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
Title
Change in Average Number of Days of Dosing - (Period 1 to Period 2)
Description
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
Title
Average Number of Daily Doses - Iloprost PD-6 (Period 1)
Description
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
Title
Average Number of Daily Doses - Iloprost PD-15 (Period 2)
Description
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
Title
Average Number of Daily Doses - Iloprost PD-15 (Period 3)
Description
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
Title
Change in Average Number of Daily Doses - (Period 1 to Period 2)
Description
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
Title
Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)
Description
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
Title
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)
Description
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
Title
Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)
Description
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
Title
Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)
Description
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
Title
New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Description
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
Title
NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)
Description
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
Title
NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)
Description
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
Title
Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)
Description
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
Title
Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))
Description
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
Title
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28
Description
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
Title
Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 1.3.5: Drugs and toxins PAH confirmed by the most recent right heart catheterization showing: Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion. Pulmonary vascular resistance (PVR) > 240 dyn-sec/cm^5 Compliant with a treatment regimen of commercial iloprost inhalation (Ventavis® 5 μg) using the I-neb® AAD® equipped with the PD-6 for at least 4 weeks prior to screening. Pulmonary function tests (PFTs) including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and total lung capacity (TLC), performed within 6 months of screening. If taking other medications for PAH, these must have been stable for 60 days prior to baseline. If taking corticosteroids, these must have been stable for 60 days prior to baseline. Women of childbearing potential with a negative urine pre-treatment pregnancy test at baseline and who: consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of < 1%, are sexually abstinent, or have a vasectomized partner. A woman is considered to have childbearing potential unless she meets at least one of the following criteria: Previous bilateral salpingo-oophorectomy or hysterectomy Premature ovarian failure confirmed by a specialist gynecologist XY genotype, Turner syndrome, uterine agenesis Is aged > 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months 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: Concomitant active opportunistic infections within 6 months prior to screening Detectable viral load within 6 months of screening CD4+ T-cell count < 200 mm^3 within 3 months of screening Changes in antiretroviral regimen within 3 months of screening Anticipated changes in antiretroviral regimen during study periods 1 or 2 Using inhaled pentamidine Systemic hypotension with systolic blood pressure < 95 mmHg. Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement). History of left-sided heart disease, including any of the following: hemodynamically significant aortic or mitral valve disease restrictive or congestive cardiomyopathy left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography coronary artery disease with continuing symptoms of angina pectoris life-threatening cardiac arrhythmias Atrial septostomy within 1 year. History of pulmonary embolism prior to diagnosis of PAH unless it can be documented that chronic thromboembolic pulmonary hypertension (CTEPH) has been specifically excluded (e.g., ventilation/perfusion (VQ) scan, pulmonary angiogram). Restrictive lung disease: TLC < 60% of normal predicted value. Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 or clinically relevant chronic obstructive lung disease or asthma (including any patient requiring concomitant medication to control symptoms of bronchospasm including as needed (p.r.n.) use). Clinically relevant bleeding disorder or active bleeding. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C or hepatic cirrhosis. Pregnant or breast-feeding. Chronic renal insufficiency, as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis. Hemoglobin < 75% of the lower limit of normal range. Any condition that prevents compliance with the protocol or adherence to therapy or ability to provide informed consent. Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment.
Facility Information:
Facility Name
University of South Alabama Medical
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Arizona Pulmonary Associates, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Kaiser Foundation Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
West Los Angeles VA Healthcare Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Central Florida Pulmonary Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Suncoast Lung Research, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracus
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0564
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University, The Dorothy M. Davis Heart & Lung Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
INTEGRIS Baptist Medical Center, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center-Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Central Utah Clinic, P.C.
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Comprehensive Cardiovascular Care Group LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

We'll reach out to this number within 24 hrs