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"
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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®.
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®.
Pulmonary Associates
Phoenix, Arizona, United States
UCSD Medical Center, Thorton Hospital
La Jolla, California, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
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)
Time frame: 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)
Time frame: 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)
Time frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
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)
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Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Hospital
Baltimore, Maryland, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
...and 2 more locations
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15