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

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"

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 Overview

• Status: Terminated
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug: Iloprost PD-6; Drug: Iloprost PD-15

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: 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 Names: Ventavis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Actelion
• Investigators: Principal Investigator: David Baratz, MD, Pulmonary Associates; Principal Investigator: Michael A Mathier, MD, University of Pittsburgh Medical Center; Principal Investigator: Ramagopal Tumuluri, MD, Aurora Medical Group - Cardiovascular Services; Principal Investigator: Charles J. Burch, MD, Diagnostic Research Group; Principal Investigator: Ben DeBoisblanc, MD, Ochsner Health System; 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

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 27, 2007
• First Submitted That Met QC Criteria: April 27, 2007
• First Posted (Estimate): May 1, 2007

Study Record Updates

• Last Update Posted (Estimate): April 4, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; PAH; iloprost; Ventavis; Actelion Pharmaceuticals; Cotherix
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: C200-008