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

Pulmonary Hypertension Clinical Trial

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"

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00467896
• Other study ID #: C200-008
• Status: Terminated
• Phase: Phase 2
• First received: April 27, 2007
• Last updated: March 27, 2013
• Start date: September 2006
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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"

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: June 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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®.
• 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®.

Locations

Country	Name	City	State
United States	University of Maryland Hospital	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	UCSD Medical Center, Thorton Hospital	La Jolla	California
United States	Aurora Medical Group - Cardiovascular Services	Milwaukee	Wisconsin
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Pulmonary Associates	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Diagnostic Research Group	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes