The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting - Full Text View

Purpose

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"

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: Iloprost PD-6 Drug: Iloprost PD-15	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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"

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

Inhalation-times Rate - Iloprost PD-6 (Period I) [ Time Frame: 37 days prior to first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days prior to first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days prior to first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days prior to first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days prior to first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: 37 days following first dose of iloprost PD-15 ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1, prior to first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1 and Day 7, following the first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1, prior to first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1 and Day 7, following the first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1, prior to first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Day 1 and Day 7, following the first dose of iloprost PD-15 ] [ Designated as safety issue: Yes ]
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

Enrollment:	62
Study Start Date:	September 2006
Study Completion Date:	June 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Iloprost 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 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®. Other Name: Ventavis Drug: Iloprost PD-15 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®. Other Name: Ventavis

Arms

Assigned Interventions

Experimental: Iloprost

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

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®.

Other Name: Ventavis

Drug: Iloprost PD-15

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®.

Other Name: Ventavis

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467896

Locations

United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, California
UCSD Medical Center, Thorton Hospital
La Jolla, California, United States, 92037
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Diagnostic Research Group
San Antonio, Texas, United States, 78229
United States, Wisconsin
Aurora Medical Group - Cardiovascular Services
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Actelion

Investigators

Principal Investigator:	Michael A Mathier, MD	University of Pittsburgh
Principal Investigator:	Ramagopal Tumuluri, MD	Aurora Medical Group - Cardiovascular Services
Principal Investigator:	Charles J. Burch, MD	Diagnostic Research Group
Principal Investigator:	David Baratz, MD	Pulmonary Associates
Principal Investigator:	Ben DeBoisblanc, MD	Ochsner Clinic Foundation
Principal Investigator:	Adaani Frost, MD	Baylor College of Medicine
Principal Investigator:	Victor Test, MD	UCSD Medical Center, Thorton Hospital
Principal Investigator:	Sif Handsdottir, MD	University of Iowa Hospital & Clinics
Principal Investigator:	Myung Park, MD	University of Maryland Hospital
Principal Investigator:	Evelyn Horn, MD	New York Presbyterian Hospital
Principal Investigator:	Erika Berman-Rosenzweig, MD	Columbia University
Principal Investigator:	Victor Tapson, MD	Duke University

More Information

No publications provided

Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT00467896 History of Changes
Other Study ID Numbers:	C200-008
Study First Received:	April 27, 2007
Results First Received:	September 27, 2012
Last Updated:	March 27, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

PAH
iloprost
Ventavis

Pulmonary Arterial Hypertension
Actelion Pharmaceuticals
Cotherix

Additional relevant MeSH terms:

Respiratory Aspiration
Hypertension
Hypertension, Pulmonary
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases

Lung Diseases
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013