NCT00467896

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"

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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"

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
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®.
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®.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-11-01
• Completion: 2011-06-01
• First posted: 2007-05-01
• Last updated: 2013-04-04
• Results posted: 2012-10-26

Locations

12 sites across 1 country: United States