Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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The main aim of the observational VENTASTEP study was to investigate the association between changes in clinical outcome measures and changes in device outcome measures in PAH patients using the new Breelib nebulizer in a real life setting. The study was not designed to investigate or confirm the effectiveness and safety of iloprost.

Official Title
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Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension

Conditions
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Hypertension, Pulmonary

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ventavis-treatment naïve patients aged ≥18 years at initiation of Ventavis (Iloprost) therapy diagnosed with pulmonary arterial hypertension WHO FC III Patients who are planned to be treated with Ventavis (Iloprost) and where the decision to use the Breelib has been agreed by physician and patient Patients who are willing to wear a smart watch (iWatch2) over the observation period of 3 months ± 2 weeks Signed informed consent Exclusion Criteria: Patients allergic to Nickel and Methacrylates Patients participating in an investigational program with interventions outside of routine clinical practice

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 |
| --- | --- |
| BAYQ6256_Ventavis<br>Patients with pulmonary hypertension who agree to be treated with Ventavis (Iloprost) at the discretion of physician | Drug: Iloprost (Ventavis, BAYQ6256)<br>* Using Breelib device<br>Device: Breelib nebulizer<br>* Used for inhalation of Ventavis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Six-minute walking distance (6MWD) | Clinical outcome measured by study nurse. | Baseline and 3 months | 
| Change of laboratory results of the biomarkers NT-pro BNP/BNP |  | Baseline and 3 months | 
| Change of Health related Quality of Life-EuroQol five dimensions questionnaire (EQ-5D) |  | Baseline and 3 months | 
| Change of World Health Organization functional class |  | Baseline and 3 months | 
| Change of Distance Walked per day |  | Baseline and 3 months | 
| Change of Number of Steps per day |  | Baseline and 3 months | 
| Change of number of floors climbed (10 feet) per day |  | Baseline and 3 months | 
| Change of time spent at home per day |  | Baseline and 3 months | 
| Change of number of relevant location changes per day |  | Baseline and 3 months | 
| Change of number of times leaving home per day |  | Baseline and 3 months | 
| Change of number of times standing up per day |  | Baseline and 3 months | 
| Change of 6MWD | Device based outcome measured by smart device. | Baseline and 3 months | 
| Heart rates during baseline and observation period |  | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average daily inhalation duration per session |  | Up to 3 months | 
| The average number of daily inhalations |  | Up to 3 months | 
| Change of sleep quality | Measured by Pittsburgh Sleep Quality Index (PSQI). | Baseline and 3 months | 
| Incidence of AEs |  | Up to 3 months after first inhalation | 
| Change of heart rate during 6MWD |  | Baseline and 3 months | 
| The average daily proportion of complete/incomplete inhalations |  | Up to 3 months | 
| The average association between physical activity level (wearable device based) and time to last inhalation |  | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary arterial hypertension, PAH