Clinical trial NCT00467896: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: PAH
iloprost
Ventavis
Pulmonary Arterial Hypertension
Actelion Pharmaceuticals
Cotherix
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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"


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

Primary outcomes:
measure: Inhalation-times Rate - Iloprost PD-6 (Period I)
timeFrame: 37 days prior to first dose of iloprost PD-15
measure: Inhalation-times Rate - Iloprost PD-15 (Period II)
timeFrame: 37 days following first dose of iloprost PD-15
measure: Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
timeFrame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
Secondary outcomes:
measure: Number of Daily Inhalations - Iloprost PD-6 (Period I)
timeFrame: 37 days prior to first dose of iloprost PD-15
measure: Number of Daily Inhalations - Iloprost PD-15 (Period II)
timeFrame: 37 days following first dose of iloprost PD-15
measure: Daily Inhalation Duration - Iloprost PD-6 (Period I)
timeFrame: 37 days prior to first dose of iloprost PD-15
measure: Daily Inhalation Duration - Iloprost PD-15 (Period II)
timeFrame: 37 days following first dose of iloprost PD-15
measure: Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
timeFrame: 37 days prior to first dose of iloprost PD-15
measure: Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
timeFrame: 37 days following first dose of iloprost PD-15
measure: Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
timeFrame: 37 days prior to first dose of iloprost PD-15
measure: Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
timeFrame: 37 days following first dose of iloprost PD-15
measure: Systolic Blood Pressure - Iloprost PD-6 (Period I)
timeFrame: Day 1, prior to first dose of iloprost PD-15
measure: Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
timeFrame: Day 1 and Day 7, following the first dose of iloprost PD-15
measure: Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
timeFrame: Day 1, prior to first dose of iloprost PD-15
measure: Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
timeFrame: Day 1 and Day 7, following the first dose of iloprost PD-15
measure: Heart Rate (HR) - Iloprost PD-6 (Period I)
timeFrame: Day 1, prior to first dose of iloprost PD-15
measure: Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
timeFrame: Day 1 and Day 7, following the first dose of iloprost PD-15
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: La Jolla
country: United States
facility: UCSD Medical Center, Thorton Hospital
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Diagnostic Research Group
state: Texas
city: Milwaukee
country: United States
facility: Aurora Medical Group - Cardiovascular Services
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Michael A Mathier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aurora Medical Group - Cardiovascular Services
name: Ramagopal Tumuluri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostic Research Group
name: Charles J. Burch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary Associates
name: David Baratz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ochsner Health System
name: Ben DeBoisblanc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Adaani Frost, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD Medical Center, Thorton Hospital
name: Victor Test, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Hospital & Clinics
name: Sif Handsdottir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland Hospital
name: Myung Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital
name: Evelyn Horn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Erika Berman-Rosenzweig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Victor Tapson, MD
role: PRINCIPAL_INVESTIGATOR
References: