Ignite Creation Date:
2024-05-06 @ 8:47 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02826252
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2016-07-05
Brief Title:
Examination of Ventavis Iloprost Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μgmL V10 to 20 μgmL V20
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
VENTASWITCH Examination of Ventavis Iloprost Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μgmL V10 to 20 μgmL V20
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENTASWITCH
Brief Summary:
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis Iloprost 10 μgmL to Ventavis Iloprost 20 μgmL formulation
Detailed Description:
The VENTASWITCH study will be a local prospective and retrospective observational case-crossover study Data are collected and downloaded from the I-Neb AAD Adaptive Aerosol Delivery System Two data collection periods are planned period one data collection from the last 3 months using Ventavis Iloprost 10 μgmL V10 before the index date of switching to Ventavis Iloprost 20 μgmL V20 retrospective part and period two data collection for 3 months using V20 from index date prospective part
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None