The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
- Conditions
- Pulmonary Hypertension
- Interventions
- Registration Number
- NCT00467896
- Lead Sponsor
- Actelion
- Brief Summary
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"
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Iloprost Iloprost PD-6 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. Iloprost Iloprost PD-15 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.
- Primary Outcome Measures
Name Time Method Inhalation-times Rate - Iloprost PD-6 (Period I) 37 days prior to first dose of iloprost PD-15 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)
Inhalation-times Rate - Iloprost PD-15 (Period II) 37 days following first dose of iloprost PD-15 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)
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15) 37 days prior to first dose of iloprost PD-15/37 days following first dose of 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)
- Secondary Outcome Measures
Name Time Method Number of Daily Inhalations - Iloprost PD-6 (Period I) 37 days prior to first dose of iloprost PD-15 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)
Number of Daily Inhalations - Iloprost PD-15 (Period II) 37 days following first dose of iloprost PD-15 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)
Daily Inhalation Duration - Iloprost PD-6 (Period I) 37 days prior to first dose of iloprost PD-15 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)
Daily Inhalation Duration - Iloprost PD-15 (Period II) 37 days following first dose of iloprost PD-15 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)
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) 37 days prior to first dose of iloprost PD-15 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)
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) 37 days following first dose of iloprost PD-15 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)
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) 37 days prior to first dose of iloprost PD-15 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)
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) 37 days following first dose of iloprost PD-15 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)
Systolic Blood Pressure - Iloprost PD-6 (Period I) Day 1, prior to first dose of iloprost PD-15 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
Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) Day 1 and Day 7, following the first dose of iloprost PD-15 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
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) Day 1, prior to first dose of iloprost PD-15 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
Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) Day 1 and Day 7, following the first dose of iloprost PD-15 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
Heart Rate (HR) - Iloprost PD-6 (Period I) Day 1, prior to first dose of iloprost PD-15 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
Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) Day 1 and Day 7, following the first dose of iloprost PD-15 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
Trial Locations
- Locations (12)
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
UCSD Medical Center, Thorton Hospital
🇺🇸La Jolla, California, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Diagnostic Research Group
🇺🇸San Antonio, Texas, United States
Aurora Medical Group - Cardiovascular Services
🇺🇸Milwaukee, Wisconsin, United States