The Power 15 Study: Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

Study Overview
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Brief Summary
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A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 Power 15 Study

Official Title
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A Comparison of Safety and Inhalation Times of Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 Power 15 Study

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: Iloprost PD-6
* Drug: Iloprost PD-15


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-85 years Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine) On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6 Exclusion Criteria: Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit Receipt of atrial septostomy within the 6 months preceding Screening History of left-sided heart disease Clinically relevant obstructive lung disease Chronic renal or liver disease Uncontrolled systemic hypertension or hypotension Cerebrovascular event within the 6 months preceding Screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iloprost<br>The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control. | Drug: Iloprost PD-6<br>* Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.<br>* Other names: Ventavis;Drug: Iloprost PD-15<br>* Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.<br>* Other names: Ventavis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalation-times Rate - Iloprost PD-6 (Period I) | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15 | 
| Inhalation-times Rate - Iloprost PD-15 (Period II) | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days following first dose of iloprost PD-15 | 
| Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15) | Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Daily Inhalations - Iloprost PD-6 (Period I) | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15 | 
| Number of Daily Inhalations - Iloprost PD-15 (Period II) | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days following first dose of iloprost PD-15 | 
| Daily Inhalation Duration - Iloprost PD-6 (Period I) | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15 | 
| Daily Inhalation Duration - Iloprost PD-15 (Period II) | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days following first dose of iloprost PD-15 | 
| Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15 | 
| Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days following first dose of iloprost PD-15 | 
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days prior to first dose of iloprost PD-15 | 
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (< 12.5%, ≥ 12.5% to < 100%, and Full) | 37 days following first dose of iloprost PD-15 | 
| Systolic Blood Pressure - Iloprost PD-6 (Period I) | SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 | 
| Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 | 
| Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 | 
| Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 | 
| Heart Rate (HR) - Iloprost PD-6 (Period I) | HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 | 
| Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix