NCT00467896

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"

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

4.2 years

First QC Date

April 27, 2007

Results QC Date

September 27, 2012

Last Update Submit

March 27, 2013

Conditions

Pulmonary Hypertension

Keywords

PAHiloprostVentavisPulmonary Arterial HypertensionActelion PharmaceuticalsCotherix

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • Number of Daily Inhalations - Iloprost PD-6 (Period I)

    37 days prior to first dose of iloprost PD-15

  • Number of Daily Inhalations - Iloprost PD-15 (Period II)

    37 days following first dose of iloprost PD-15

  • Daily Inhalation Duration - Iloprost PD-6 (Period I)

    37 days prior to first dose of iloprost PD-15

  • Daily Inhalation Duration - Iloprost PD-15 (Period II)

    37 days following first dose of iloprost PD-15

  • Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)

    37 days prior to first dose of iloprost PD-15

  • +9 more secondary outcomes

Study Arms (1)

Iloprost

EXPERIMENTAL

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-6Drug: Iloprost PD-15

Interventions

Iloprost PD-6DRUG

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®.

Also known as: Ventavis
Iloprost
Iloprost PD-15DRUG

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®.

Also known as: Ventavis
Iloprost

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

UCSD Medical Center, Thorton Hospital

La Jolla, California, 92037, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Hospital

Baltimore, Maryland, 21201, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Diagnostic Research Group

San Antonio, Texas, 78229, United States

Location

Aurora Medical Group - Cardiovascular Services

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Limitations and Caveats

Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.

Results Point of Contact

Title
Wade Benton, Pharm D / Director, Medical Affairs Veletri and Ventavis
Organization
Actelion Pharmaceuticals, US, Inc.
wade.benton@actelion.com
(650) 624-6900

Study Officials

  • 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

  • David Baratz, MD

    Pulmonary Associates

    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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2007

First Posted

May 1, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2010

Study Completion

June 1, 2011

Last Updated

April 4, 2013

Results First Posted

October 26, 2012

Record last verified: 2013-03

Locations

US(12)