Skip to main content
OpenTrials
Completed

NCT Number: NCT02826252

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iloprost,(Ventavis, BAYQ6256)

Drug

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

I-Neb AAD system

Device

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

Primary outcomes

  1. Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL

    Time frame: Up to 6 months

  2. Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL

    Time frame: Up to 6 months

Secondary outcomes

  1. Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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)

Acronym: VENTASWITCH

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.