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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventavis | The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost,(Ventavis, BAYQ6256) | Drug | Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20). |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
- participation in other clinical or interventional study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Germany |
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| 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. |
|
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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