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, 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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02826252

Acronym

VENTASWITCH

Enrollment

Registered

2016-07-07

Start date

2016-09-15

Completion date

2017-01-24

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary Arterial Hypertension (PAH)

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).

Interventions

DRUGIloprost,(Ventavis, BAYQ6256)

Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).

DEVICEI-Neb AAD system

Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.

Study design

Observational model

CASE_CROSSOVER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

\- participation in other clinical or interventional study.

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026