Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

Study Overview
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Brief Summary
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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.

Official Title
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DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Ventavis (Iloprost, BAYQ6256)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥18 years Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification. WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III Able and willing to give written informed consent for participation in the study Exclusion Criteria: Key contra indications: Hypersensitivity to the active substance or to any of the excipients. Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage). Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision; Severe arrhythmias; Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months. Pulmonary hypertension due to venous occlusive disease. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Ventavis (Iloprost, BAYQ6256)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance for each subject assessed by the mean daily number of inhalations of Ventavis. |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iloprost Compliance