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) (VENTASWITCH)

Bayer

Status

Completed

Conditions

Hypertension, Pulmonary

Treatments

Device: I-Neb AAD system

Drug: Iloprost,(Ventavis, BAYQ6256)

Study type

Observational

Funder types

Industry

Identifiers

NCT02826252

18838

Details and patient eligibility

About

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.

Full 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).

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria