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)

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Hypertension, Pulmonary

Intervention / Treatment
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* Drug: Iloprost,(Ventavis, BAYQ6256)
* Device: I-Neb AAD system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ventavis<br>The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus. | Drug: Iloprost,(Ventavis, BAYQ6256)<br>* Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).<br>Device: I-Neb AAD system<br>* Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL |  | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Arterial Hypertension (PAH)