Back to resultsThe "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Primary Purpose
Pulmonary Hypertension
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iloprost PD-6
Iloprost PD-15
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix
Eligibility Criteria
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
Sites / Locations
- Pulmonary Associates
- UCSD Medical Center, Thorton Hospital
- University of Iowa Hospital and Clinics
- Ochsner Clinic Foundation
- University of Maryland Hospital
- Columbia University Medical Center
- New York Presbyterian Hospital
- Duke University Medical Center
- University of Pittsburgh Medical Center
- Baylor College of Medicine
- Diagnostic Research Group
- Aurora Medical Group - Cardiovascular Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iloprost
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467896
Brief Title
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Official Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
5. Study Description
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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iloprost
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Iloprost PD-6
Other Intervention Name(s)
Ventavis
Intervention Description
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®.
Intervention Type
Drug
Intervention Name(s)
Iloprost PD-15
Other Intervention Name(s)
Ventavis
Intervention Description
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®.
Primary Outcome Measure Information:
Title
Inhalation-times Rate - Iloprost PD-6 (Period I)
Description
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
Title
Inhalation-times Rate - Iloprost PD-15 (Period II)
Description
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
Title
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
Description
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
Secondary Outcome Measure Information:
Title
Number of Daily Inhalations - Iloprost PD-6 (Period I)
Description
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 prior to first dose of iloprost PD-15
Title
Number of Daily Inhalations - Iloprost PD-15 (Period II)
Description
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
Title
Daily Inhalation Duration - Iloprost PD-6 (Period I)
Description
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
Title
Daily Inhalation Duration - Iloprost PD-15 (Period II)
Description
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
Title
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
Description
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
Title
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
Description
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
Title
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
Description
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
Title
Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
Description
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
Title
Systolic Blood Pressure - Iloprost PD-6 (Period I)
Description
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
Title
Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Description
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
Title
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
Description
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
Title
Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Description
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
Title
Heart Rate (HR) - Iloprost PD-6 (Period I)
Description
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
Title
Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Description
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
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Mathier, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramagopal Tumuluri, MD
Organizational Affiliation
Aurora Medical Group - Cardiovascular Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles J. Burch, MD
Organizational Affiliation
Diagnostic Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Baratz, MD
Organizational Affiliation
Pulmonary Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben DeBoisblanc, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adaani Frost, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Test, MD
Organizational Affiliation
UCSD Medical Center, Thorton Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sif Handsdottir, MD
Organizational Affiliation
University of Iowa Hospital & Clinics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myung Park, MD
Organizational Affiliation
University of Maryland Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Evelyn Horn, MD
Organizational Affiliation
New York Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Berman-Rosenzweig, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victor Tapson, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCSD Medical Center, Thorton Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diagnostic Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aurora Medical Group - Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
We'll reach out to this number within 24 hrs