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)

Hypertension, Pulmonary Clinical Trial

— VENTASWITCH  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826252
• Other study ID #: 18838
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: March 14, 2017
• Start date: September 15, 2016
• Est. completion date: January 24, 2017

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 24, 2017
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Respiratory Aspiration

Intervention

Drug:
• Iloprost,(Ventavis, BAYQ6256)
Ventavis (Iloprost) nebulizer solution for inhalation as 10 µg/mL (V10) and 20 µg/mL (V20).

Device:
• I-Neb AAD system
Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL		Up to 6 months
Primary	Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL		Up to 6 months
Secondary	Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL		Up to 6 months

External Links

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