Clinical trial 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)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension (PAH)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus which is executed for Bayer by the company Contra Care GmbH, Nürnberg. Patients who are enrolled in the program and repeatedly experienced extended inhalation times with Ventavis (Iloprost) 10 μg/mL which could possibly result in incomplete inhalations, are currently being switched to Ventavis (Iloprost) 20 μg/mL by their physician.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL
timeFrame: Up to 6 months
measure: Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
timeFrame: Up to 6 months
Secondary outcomes:
measure: Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Many locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: