Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Study Overview
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Brief Summary
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Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.

Official Title
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Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension

Conditions
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Hypertension, Pulmonary

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients ≥ 18 years old Diagnosis of PH Planned or current treatment with Ventavis (not more than 6 month) Exclusion Criteria: Contraindications for the use of Ventavis in accordance with the local product information

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 |
| --- | --- |
| Iloprost<br>The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion. | Drug: Iloprost (Ventavis, BAYQ6256)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days without any drug administration at all |  | Up to 12 months | 
| Number of fully inhaled doses in relation to the total number of inhalations per day |  | Up to 12 months | 
| Number of missed doses per day as recommended |  | Up to 12 months | 
| Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance test (MWDT) value |  | Up to 12 months | 
| Score on dyspnea Borg CR (category ratio) 10 scale |  | Up to 12 months | 
| Patients' quality of life, assessed by validated questionnaire |  | Up to 12 months | 
| Assessment of the structural changes in the lungs using X-ray examination of the lungs |  | Up to 12 months | 
| Assessment of the structural changes in the lungs using spirography |  | Up to 12 months | 
| Assessment of lung haemodynamics using the data of echocardiography |  | Up to 12 months | 
| Assessment of lung haemodynamics using the data of catheterization |  | Up to 12 months | 
| Reason for omission of inhalation as assessed by the physician |  | Up to 12 months | 
| Concomitant medication for other indications than pulmonary hypertension |  | Up to 12 months | 
| Number of participants with adverse events (AEs) |  | Up to 12 months | 
| Severity of AEs |  | Up to 12 months | 
| AE relation to treatment |  | Up to 12 months | 
| AE treatment |  | Up to 12 months | 
| AE outcomes |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-interventional, Ventavis, Iloprost, Pulmonary hypertension, Compliance, Russian Federation