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| ID | Type | Description | Link |
|---|---|---|---|
| VE1210FR | Other Identifier | Company internal | |
| 2011/00416 | Other Identifier | Company internal |
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This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventavis (Iloprost, BAYQ6256) | Drug | Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance for each subject assessed by the mean daily number of inhalations of Ventavis. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance for each subject assessed by the mean daily number of inhalations of Ventavis | Up to 6 months | |
| Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
Key contra indications:
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Patients aged ≥18 years and diagnosed with PAH (Pulmonary Arterial Hypertension), WHO/NYHA functional class III, Group I of the Dana point Pulmonary Hypertension Classification and newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I-Neb AAD device for the application.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | France |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Dyspnea Borg Category Ration 10 Scale values | 6 and 12 months |
| Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires) | 6 and 12 months |
| Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale | Up to 12 months |
| Population characteristics | sociodemography, clinical aspects, risk factors | At baseline |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |