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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-15

Study Completion Date

2017-01-24

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.

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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).

Conditions

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Hypertension, Pulmonary

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

OTHER

Study Groups

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Ventavis

The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.

Iloprost,(Ventavis, BAYQ6256)

Intervention Type DRUG

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

I-Neb AAD system

Intervention Type DEVICE

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

Interventions

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Iloprost,(Ventavis, BAYQ6256)

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

Intervention Type DRUG

I-Neb AAD system

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

Intervention Type DEVICE

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.