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 μg/mL (V10) to 20 μg/mL (V20)

Completed

• Conditions: Hypertension, Pulmonary
• Interventions: Drug: Iloprost,(Ventavis, BAYQ6256); Device: I-Neb AAD system

• Registration Number: NCT02826252
• Lead Sponsor: Bayer

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 μg/mL to Ventavis (Iloprost) 20 μg/mL 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 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-07
• Study Start: 2016-09-15
• Primary Completion: 2016-11-15
• Study Completion: 2017-01-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients aged ≥18 years at time of signing informed consent.
• Patients, diagnosed with group 1 PAH.
• Patients must be enrolled in the German Ventavis patient support program Ventaplus.
• Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
• Patients must have been on V10 therapy for at least 2 weeks.
• Written informed consent must be obtained.

Read More

Exclusion Criteria

• participation in other clinical or interventional study.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventavis	Iloprost,(Ventavis, BAYQ6256)	The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.
Ventavis	I-Neb AAD system	The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.

Primary Outcome Measures

Name	Time	Method
Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL	Up to 6 months
Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL	Up to 6 months